Penumbra, Inc.
FDA 510(k) medical device clearances.
Top product codes for Penumbra, Inc.
Recent clearances by Penumbra, Inc.
- K251949 — INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
- K252612 — INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing
- K250079 — Ruby XL System
- K242104 — Penumbra System (Reperfusion Catheter RED 72)
- K242033 — Access25 Delivery Microcatheter
- K242520 — Element Vascular Access System
- K242075 — Indigo® Aspiration System Lightning Bolt Aspiration Tubing
- K242319 — Indigo® Aspiration System Aspiration Catheter 6X
- K241399 — Indigo® Lightning Flash Aspiration System Select + Catheter
- K233201 — MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)
- K240030 — Indigo® Aspiration System - Lightning® Flash
- K230284 — Penumbra LP Coil System
- K223186 — Indigo® Aspiration System Lightning Bolt Aspiration Tubing
- K222358 — Indigo Aspiration System - Lightning Flash
- K222808 — Penumbra System (Reperfusion Catheter RED 43)
- K221822 — BENCHMARK BMX81 Access System
- K220683 — INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)
- K213390 — Benchmark BMX96 Access System
- K212838 — Benchmark Intracranial Access System
- K211654 — Penumbra System (Reperfusion Catheter RED 72)
- K211411 — Penumbra System (RED 68 Reperfusion Catheter)
- K203440 — Penumbra System (Reperfusion Catheter RED 62)
- K210323 — Indigo Aspiration System - Lightning Aspiration Tubing
- K210083 — Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7
- K202821 — Indigo Aspiration System - Aspiration Catheter 12 and Separator 12
- K202251 — Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)
- K193595 — Indigo Aspiration System - Aspiration Catheter 7 and Separator 7
- K201271 — Benchmark BMX96 Access System
- K192981 — Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12
- K200771 — Indigo Aspiration System Lightning Aspiration Tubing
- K193244 — Indigo Aspiration System Lightning Aspiration Tubing
- K191946 — Penumbra System Penumbra JET 7X
- K192833 — Indigo Aspiration System
- K192955 — Penumbra LP Coil System
- K190719 — Artemis Eye System
- K190010 — Penumbra System Reperfusion Catheter JET 7
- K190464 — Penumbra System 3D Revascularization Device
- K183296 — REAL Immersive System
- K182522 — Penumbra System (Modified 110 Aspiration Tubing)
- K173761 — Penumbra System Reperfusion Catheter JET 7
- K180008 — Penumbra System
- K180412 — Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister
- K180939 — Indigo Aspiration System - Modified 110 Aspiration Tubing
- K173614 — Penumbra Coil 400, Ruby Coil System, POD System
- K180105 — Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister
- K171332 — Artemis Neuro Evacuation Device
- K170852 — POD Packing Coil
- K163618 — INDIGO Aspiration System
- K162901 — Penumbra 3D Revascularization Device
- K161506 — Penumbra Aspiration System
- K161640 — Penumbra System ACE 68 Reperfusion Catheter
- K161523 — INDIGO Aspiration System
- K161064 — Penumbra System ACE 68 Reperfusion Catheter
- K160449 — Penumbra System, Penumbra Pump MAX
- K160533 — Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)
- K160832 — Penumbra Smart Coil
- K152699 — Apollo System
- K152541 — Penumbra System ACE 64 and ACE 68 Reperfusion Catheters
- K152840 — Lantern Delivery Microcatheter
- K151623 — Penumbra System 110 Aspiration Tubing
- K151572 — Penumbra Smart Coil
- K142870 — Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]
- K142458 — Penumbra System ACE
- K143218 — Penumbra Smart Coil
- K142321 — Benchmark Intracranial Access System
- K141134 — POD SYSTEM
- K133317 — PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX
- K132931 — APOLLO SYSTEM
- K122772 — PENUMBRA DDC CATHETERS
- K122756 — PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING
- K121917 — PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM
- K120330 — PENUMBRA COIL SYSTEM/PENUMBRA COIL 400
- K113163 — PENUMBRA SYSTEM MAX
- K111380 — NEURON MAX SYSTEM
- K103305 — PENUMBRA EMBOLIZATION COIL SYSTEM
- K100826 — PENUMBRA CATHERER 025
- K100769 — PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054
- K093970 — PICA CATHETER
- K090752 — PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS054
- K083125 — NEURON SELECT CATHETER SIZE 070
- K082290 — NEURON DELIVERY CATHETER 070
- K072718 — PENUMBRA SYSTEM
- K070970 — NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F
- K053491 — PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F
- K051758 — PENUMBRA ASPIRATION PUMP, MODEL 115V
Data sourced from openFDA. This site is unofficial and independent of the FDA.