Atlas FDA

DWP

20 FDA 510(k) clearances · Product code

89 daysmedian time to decision
265 days90th percentile
20clearances measured

FDA profile

Official device name
Dilator, Vessel, Surgical
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4475
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2013: 13 · 2014: 10 · 2015: 25 · 2016: 18 · 2017: 34 · 2018: 29
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe (K220981)Fehling Surgical Instruments, Inc.2023-04-20
Geomed Vascular Dilators (K183438)Geomed Medizin-Technik GmbH & Co.2019-09-03
Vessel Dilator (K163524)Fetzer Medical GmbH & Co. KG2017-06-29
VASCULAR PROBE, VASCULAR PROBE ES (K130896)Synovis Life Technologies, Inc.2013-04-24
INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 (K100518)Instrumed International, Inc.2010-08-31
KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS (K030788)Geister Medizin Technik GmbH2003-07-12
RDI CARDIAC INSULATION PAD (K960312)R D Intl.1996-04-19
LEMAITRE-BOOKWALTER VESSEL DEVICES (K912548)Vascutech, Inc.1991-09-18
LAPAROSCOPIC VESSEL ARTICULATOR (K911475)United States Endoscopy Group, Inc.1991-07-02
ROBICSEK PROBE/RETRACTOR (K910682)Bio-Vascular, Inc.1991-05-08
FLO-RESTER(R) VESSEL SIZER (K905159)Bio-Vascular, Inc.1991-02-07
FOGARTY VESSEL CALIBRATOR (K902143)Baxter Healthcare Corp1990-10-16
PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE) (K891786)Pioneering Technologies, Inc.1989-10-12
SURGICAL VESSEL DILATORS-CATHERIZA- (K833676)Cimed Intl., Inc.1984-03-19
VESSEL DILATOR (K832595)Abbott Laboratories1983-08-31
REUSABLE FOGARTY FLEXIBLE CALIBRATOR (K822687)American Edwards Laboratories1982-10-04
FOGARTY FLEXIBLE PROBE (K812935)American Edwards Laboratories1981-11-16
FOGARTY FLEXIBLE CALIBRATOR (K810894)American Edwards Laboratories1981-05-15
BONCHEK-SHILEY VEIN DISTENTION SYSTEM (K792134)Shiley, Inc.1979-12-04
SAPHENOUS VEIN IRRIGATION, PRESSURIZATIO (K790938)Shiley, Inc.1979-06-13

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Every clearance here is in the API, with alerts when new ones post.