DSP
SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER
- Advisory panel
- Cardiovascular
- Total cleared
- 162
Adverse events under product code DSP
product code DSP- Death
- 317
- Injury
- 566
- Malfunction
- 36,831
- Other
- 4
- Total
- 37,718
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code DSP
1–100 of 162- K250542 — AC3 Range Intra-Aortic Balloon Pump
- K232343 — AC3 Series IABP
- K201112 — AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP
- K200634 — Arrow FiberOptix Intra-Aortic Balloon Catheter Kit
- K192238 — AC3 Series Intra-Aortic Balloon Pump (IABP)
- K190101 — UltraFlex IAB
- K190117 — Fiberoptix IAB
- K181122 — CARDIOSAVE Intra-Aortic Balloon Pump
- K172305 — CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump
- K162820 — AC3 Series IABP System
- K163542 — CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case
- K151254 — CARDIOSAVE Hybrid Intra-Aortic Balloon Pump
- K133074 — MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES
- K122628 — SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES
- K120868 — MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER
- K112372 — CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP
- K112327 — SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES
- K091449 — DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02
- K082746 — ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20
- K070225 — SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE
- K063525 — DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM
- K062582 — SUPRACOR BALLOON CATHETER
- K060309 — AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES
- K041281 — DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES
- K040801 — INTRA-AORTIC BALLOON (IAB)
- K031636 — CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX
- K031569 — DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX
- K021462 — ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840
- K020257 — DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B IAB; DATASCOPE'S TRUE SHEATHLESS DL 9.5 FR. IAB; DATASCOPE'S
- K013326 — MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B
- K002256 — ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP
- K010330 — ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U
- K003598 — DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320
- K002949 — MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 40CC
- K000729 — ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL
- K994157 — DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329
- K993966 — 8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER
- K983866 — BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMP
- K981660 — Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters
- K982538 — BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP
- K970689 — IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-U
- K980850 — BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOONS
- K980780 — DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES
- K980385 — DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR OPTIONAL SHEATHLESS INSERTION WITH ACCESSORIES
- K973962 — BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS
- K974247 — 40 CC GRANDE
- K965209 — ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1)
- K963865 — 8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT NUMBER IAB-04830S
- K972113 — 30 CC AND 40 CC SUB-9 NITINOL AND 30 AND 40 CC SUB-9 STAINLESS STEEL
- K971673 — 40 CC SUMO
- K965236 — SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP)
- K963920 — 8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER,
- K964987 — DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0
- K963104 — 9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM
- K961509 — INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED
- K963187 — MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30 - 40 CC SENSATION AND NICATH 30C
- K962177 — BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT
- K961358 — ARROW SHEATHLESS INTRA-AORTIC BALLOON CATHETER
- K960713 — 8 FR.-40CC ARROW FLEX INTRA-AORTIC BALLOON CATHETER WITH BLUE FLEX TIP, PRODUCT NUMBER IAB-04840(USED WITH A 9FR.SHEATH)
- K960166 — PERCOR STAT-DL 9.5 FR. 34 & 40CC
- K954431 — PERCUTANEOUS INTRA-AORTIC BALLOON CATHETERS
- K952576 — TRANSPORT CART
- K952221 — BSC/CA 30 & 40 SENSATION, MODELS 930 & 940
- K950687 — EXTERNAL HELIUM SUPPLY (ACCESSORY FOR IABP)
- K945230 — ARROW KINK RESISTANT FLEXI-CATH INTRA-AORTIC BALLOON
- K940298 — BSC/CA MODEL 940 IAB
- K943919 — 9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER
- K942454 — DATASCOPE 95 AND 97 IAB PUMP CONSOLE
- K935184 — REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WITH HYDROMER COATING
- K944460 — DATASCOPE INTRA-AORTIC BALLOON WITH MODIFIED STAT GARD
- K936232 — BSC/CA MODEL 930 IAB, BSC/CA 30 SIDEWINDER
- K940231 — INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION
- K940178 — PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERCOR STAT-DL 10.5 FR.40CC & 50CC INTRA-AORTIC BALLOON MODIFICATION
- K932268 — MODIFICATIONS TO INTRA-AORTIC BALLOONS
- K925248 — MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS
- K926000 — 9.5 FR SIDEWINDER DL INTRA-AORTIC BALLON CATHETER
- K911000 — PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC BALLOON
- K914802 — DATASCOPE PERCOR STAT DL9.5 FR34CC INTRA-AORT BALL
- K920427 — PERCOR STAT DL 9.5 FR 40CC INTRA-AORTIC BALLOON
- K905663 — PEDIATRIC INTRA-AORTIC BALLOON CATHETERS
- K922235 — SYSTEM 97
- K924382 — BARD(R) INTRA AORTIC BALLOON
- K921638 — SYSTEM 90 INTRA-AORTIC BALLOON PUMP CONSOLE
- K915580 — BELMONT MODEL PBP INTRA-AORTIC BALLOON PUMP
- K912629 — DATASCOPE SYSTEM 95
- K913847 — SYSTEM 90 AND SYSTEM 90T
- K910997 — DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON
- K905313 — KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II
- K905056 — PERCOR STAT-DL 9.5 FR W/OPT INSERT W/O INTRO SHEAT
- K903917 — COMPACT MONITOR SMK 210,211,230,231,240
- K903344 — 9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM)
- K903930 — DATASCOPE PERCOR STAT DL 10.5 FR 50CC
- K904414 — DATASCOPE PERCOR STAT DL 9.5 FR40CC STERIL ETO GAS
- K903769 — PERCOR STAT DL 9.5 FR 34CC INTRA-AORTIC BALLOON
- K903867 — DATASCOPE PERCOR STAT DL 10.5 FR 40CC
- K903892 — DATASCOPE PERCOR STAT 8.5 FR 40CC INTRA-AORTIC BAL
- K903893 — DATASCOPE PERCOR STAT 9.5 FR 40CC INTRA-AORTIC BAL
- K904018 — DATASCOPE PERCOR STAT DL 9.5 FR 40CC INTRA-AOR BAL
- K903736 — DATASCOPE PERCOR STAT DL10.5 FR40CC IN AORTIC BAL
- K902057 — PERCOR STAT DL 8.5 FR 40CC IAB ONLY/LABELING CHANG
Data sourced from openFDA. This site is unofficial and independent of the FDA.