Atlas FDA

KPK

6 FDA 510(k) clearances · Product code

41 daysmedian time to decision
243 days90th percentile
6clearances measured

FDA profile

Official device name
Marker, Ostia, Aorto-Saphenous Vein
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4650
Medical specialty
General, Plastic Surgery
Flags
Implant
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
CORONARY VEIN GRAFT TAG MARKER (K971966)Med-Edge, Inc.1998-01-26
VOSS GRAFT MARKER (K895369)Voss Medical Products1989-09-27
SCANLAN (TM) VEIN/GRAFT HOLDER (K864919)Scanlan Intl., Inc.1987-01-12
COOK (R) VEIN GRAFT RING MARKERS (K864101)Cook, Inc.1986-10-30
FLUORO-MARK RADIOPAQUE ANATOMICAL MKR. (K801637)C.R. Bard, Inc.1980-08-27
MARKERS, STAINLESS STEEL (K770802)Cardio-Surgical, Inc.1977-06-27

Track KPK automatically

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