Holder, Heart-valve, Prosthesis
Cardiovascular · 21 CFR 870.3935
Recent MDR events
2 adverse event reports on file
Registered firms
13 firms currently registered for this product code
Sterigenics U.s., Llc
Salt Lake City, UT, US
Edwards Lifesciences Llc
IRVINE, CA, US
Abbott Medical
Saint Paul, MN, US
Medtronic Heart Valves Division
Santa Ana, CA, US
Artivion, Inc.
Kennesaw, GA, US
Riverside Machine & Engineering, Inc.
Eau Claire, WI, US
Metal Craft Machine & Engineering, Inc.
Elk River, MN, US
Edwards Lifesciences Llc
Draper, UT, US
Medtronic, Inc. (minneapolis, Mn 55447)
Minneapolis, MN, US
Abbott Medical
Plymouth, MN, US
Corcym S.r.l.
SALUGGIA Vercelli, IT
On-x Life Technologies Inc.
Austin, TX, US
Beijing Hangtian Kadi Technology R&d Institute
Beijing, CN
510(k) clearances
12 clearances for this product code
- Carbomedics, Inc.Aug 27, 1996
K962154 · CARBOMEDICS HANDLE
- Carbomedics, Inc.Apr 15, 1996
K960169 · CARBOMEDICS VALVE TESTER
- Baxter EdwardsFeb 10, 1995
K944214 · BAXTER HANDLE MODEL 1150
- Carbomedics, Inc.Jul 6, 1994
K942736 · CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE
- Baxter Healthcare CorpApr 1, 1988
K880052 · EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR
- Shiley, Inc.Jun 15, 1987
K871596 · IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU)
- American Edwards LaboratoriesNov 20, 1986
K864155 · MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS
- Shiley, Inc.Dec 10, 1981
K813276 · IONESCU-SHILEY VALVE HOLDER & HANDLE