Dilator, Vessel, Surgical
Cardiovascular · 21 CFR 870.4475
Recent MDR events
171 adverse event reports on file
- 1.5 MM GARRETT VASCULAR DILATORJun 26, 2026MalfunctionSontec Instruments, Inc.1720747-2026-00001
- 1.5 MM GARRETT VASCULAR DILATORMay 13, 2026MalfunctionSontec Instruments, Inc.MW5188133
- PROBE ES 15CM/1-1.5MMAug 22, 2022MalfunctionBaxter Healthcare Corporation1416980-2022-04354
- VASCULAR PROBESSep 28, 2021MalfunctionBaxter Healthcare Corporation1416980-2021-05966
- VASCULAR PROBESSep 21, 2021MalfunctionBaxter Healthcare Corporation1416980-2021-05844
- VASCULAR PROBESNov 13, 2020InjuryBaxter Healthcare Corporation1416980-2020-07105
- NISep 29, 2020InjuryBaxter Healthcare Corporation1416980-2020-06064
- VASCULAR PROBEJul 21, 2020InjuryBaxter Healthcare Corporation1416980-2020-04148
- VASCULAR PROBEJul 21, 2020InjuryBaxter Healthcare Corporation1416980-2020-04150
- VASCULAR PROBEOct 4, 2019MalfunctionBaxter Healthcare - Saint Paul1416980-2019-05433
Event type breakdown
Recalls
1 recall events for this product code
Registered firms
57 firms currently registered for this product code
Ultimate Medical Products Ltd.
SHARJAH Ash Shariqah, AE
Baxter Healthcare Corporation
ROUND LAKE, IL, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Adler Instrument Company
Brooksville, FL, US
Geister Medizintechnik Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Teleflex Medical Llc
Morrisville, NC, US
Aesculap, Inc.
CENTER VALLEY, PA, US
Fehling Instruments Gmbh
KARLSTEIN Bavaria, DE
Aspen Surgical Products, Inc.
Caledonia, MI, US
Instrumed Gmbh Dba Avalign German Specialty Instruments
TUTTLINGEN Baden-Wurttemberg, DE
Integra Lifesciences Corporation
Princeton, NJ, US
Integra Lifesciences Corporation
CINCINNATI, OH, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Cunningham Woodland, Inc.
Hyannis, MA, US
Instrumed International Inc Dba Avalign German Specialty Instruments
SCHAUMBURG, IL, US
Jarit Gmbh
Rietheim-Weilheim Baden-Wurttemberg, DE
Deroyal Industries, Inc.
POWELL, TN, US
Phoenix Instruments, Inc.
Lisle, IL, US
Sontec Instruments, Inc.
CENTENNIAL, CO, US
August Reuchlen Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Surgix Medical Llc
Spring, TX, US
510(k) clearances
20 clearances for this product code
- Fehling Surgical Instruments, Inc.Apr 20, 2023
K220981 · SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe
- Geomed Medizin-Technik GmbH & Co.Sep 3, 2019
K183438 · Geomed Vascular Dilators
- Fetzer Medical GmbH & Co. KGJun 29, 2017
K163524 · Vessel Dilator
- Synovis Life Technologies, Inc.Apr 24, 2013
K130896 · VASCULAR PROBE, VASCULAR PROBE ES
- Instrumed International, Inc.Aug 31, 2010
K100518 · INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054
- Geister Medizin Technik GmbHJul 12, 2003
K030788 · KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS
- R D Intl.Apr 19, 1996
K960312 · RDI CARDIAC INSULATION PAD
- Vascutech, Inc.Sep 18, 1991
K912548 · LEMAITRE-BOOKWALTER VESSEL DEVICES