DRE
VESSEL DILATOR
- Advisory panel
- Cardiovascular
- Total cleared
- 104
Adverse events under product code DRE
product code DRE- Death
- 100
- Injury
- 832
- Malfunction
- 597
- Other
- 3
- Total
- 1,532
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 DRE
1–100 of 104- K253616 — ProtekDilate Vascular Access Kit
- K251325 — VersaCross Connect Transseptal Dilator
- K242229 — Micro Ace Gold Advanced Micro Access System
- K241720 — VersaCross Connect Transseptal Dilator
- K233647 — VersaCross Connect Transseptal Dilator
- K232609 — Micro Ace Advanced Micro Access System
- K223472 — TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013)
- K212784 — TightRail Guardian Motorized Dilator Sheath
- K211679 — Xtractor device
- K210734 — Endovascular Dilator and Sets
- K201288 — ExpanSure Large Access Transseptal Dilator
- K192283 — MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator
- K200379 — Super Sheath
- K192195 — Sterile Dilator
- K190175 — S-MAK XL
- K182064 — ExpanSure Transseptal Dilation System
- K183036 — Dilator Sets
- K182914 — MC3 Vascular Access Kit 21030
- K172487 — Coaxial Dilator Set (Micro-Introducer)
- K162389 — Medcomp Vessel Dilator
- K170616 — van Andel Dilatation Catheter
- K162181 — Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set
- K161336 — VSI StraitSet micro-introducer kit
- K150932 — Sheath Introducer
- K161333 — TightRail Sub-C Rotating Dilator Sheath
- K151877 — MicroTract Access System
- K151076 — MicroTaper Needle Introducer Set
- K150360 — TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath
- K141070 — SUPER SHEATH
- K142301 — Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath
- K142546 — TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath
- K141148 — EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET
- K141131 — TIGHTRAIL MINI
- K140047 — LEXICONTURE MECHANICAL DILATOR SHEATH SET
- K133631 — LEXIPLIANT DILATOR SHEATH SET
- K132713 — NMI COAXIAL MICROINTRODUCER SET
- K123842 — LAWMAX DILATOR
- K130791 — PRELUDE SHEATH INTRODUCER
- K123445 — NMI COAXIAL MICROINTRODUCER SET
- K120349 — SONIXGPS VASCULAR ACCESS NEEDLE KIT
- K103421 — ARSTASIS DILATOR ADAPTER
- K093554 — RETROFLEX DILATOR KIT
- K092378 — SPECTRANETICS VISISHEATH DILATOR SHEATH
- K091584 — MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE
- K081940 — AVALON ELITE VASCULAR ACCESS KIT
- K082075 — HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER
- K073035 — PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS
- K071330 — GALTSTICK INTRODUCER SYSTEM
- K070749 — ESTECH PERCUTANEOUS INSERTION DILATOR KIT
- K070159 — PRELUDE SHEATH INTRODUCER
- K062554 — STARCLOSE HEX-HUB DILATOR
- K061000 — EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0
- K052557 — SUPER SHEATH INTRODUCER SHEATH
- K050962 — MERIT PRELUDE SHEATH INTRODUCER
- K031691 — MERIT MAK (MINI ACCESS KIT)
- K030260 — GELBFISH FLEX VASCULAR DILATOR
- K023507 — MODIFICATION TO GELBFISH VASCULAR DILATORS
- K012256 — GELBISH VASCULAR DILATOR
- K010055 — COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH
- K000737 — COAXIAL DILATOR SET
- K974617 — PERIPHERAL VASCULAR DILATOR
- K980282 — URESIL DILATOR WITH RADIOPAQUE MARKER
- K974640 — COAXIAL DILATOR SET
- K970470 — EVT EXPANDABLE SHEATH
- K970392 — CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM
- K945586 — FLEXIBLE DILATING SHEATH
- K963388 — VESSEL DILATOR
- K960917 — PERCUGLIDE
- K914555 — WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL (MODI)
- K913027 — VESSEL DILATOR
- K912050 — NOVOSTE VESSEL DILATER
- K905416 — VESSEL DILATOR
- K904476 — VESSEL DILATOR
- K902469 — BYRD DILATOR SHEATH SET - TEFLON
- K901815 — MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY
- K896096 — SOLOSTICK (AMPLATZ DILATOR NEEDLE)
- K894330 — DAIG VESSEL DILATOR
- K882238 — VESSEL DILATOR AND INTRODUCER SHEATH
- K881073 — SHILEY FEMORAL CANNULAE INTRODUCER KIT
- K874738 — 10 AND 12 FRENCH VESSEL DILATORS
- K875327 — MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT
- K872724 — SHEATH/DILATORS
- K870413 — PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR)
- K871148 — URESIL CAROTID ARTERY SIZERS
- K862288 — MODIFICATION OF TISSUE DILATOR
- K860161 — HEART CATHETERIZATION TRAY
- K850337 — CARDIAC CATHETERIZATION PACK
- K843261 — ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD
- K842113 — AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT
- K841995 — 10.5 FRENCH DILATOR, 15CM, W/LUER LOCK
- K840671 — CARDIAC CATHETERIZATION PACK
- K840017 — VERTEX PERCUTANEOUS CATHETER INTRODUC
- K840022 — HEART CATHETERIZATION TRAY SET
- K833965 — 8 FRENCH DILATOR 15CM, W/LUER LOCK
- K831190 — VESSEL DILATOR
- K822595 — VESSEL DILATOR
- K813461 — PERCUTANEOUS ENTRY NEEDLE, SELDINGER
- K813125 — MICRO TRANSDUCER CATHETERS
- K810859 — SINGLE USE SELDINGER/COURNAND PERC. NDL
- K802327 — SHEATH DILATOR SET
Data sourced from openFDA. This site is unofficial and independent of the FDA.