510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KPKClass II

Marker, Ostia, Aorto-Saphenous Vein

21 CFR 878.4650 / General, Plastic Surgery
FDA source (opens on fda.gov)

KPK is the FDA product code for Marker, Ostia, Aorto-Saphenous Vein, a class II device type, regulated under 21 CFR 878.4650. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KPK
Device name
Marker, Ostia, Aorto-Saphenous Vein
Regulation
21 CFR 878.4650
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
0

Clearances, product code KPK

By decision year
6 clearances under product code KPK with a decision year between 1977 and 1998, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KPK by decision year
YearClearances
19771
19801
19861
19871
19891
19981

Applicants with the most clearances

Product code KPK
Applicants holding the most 510(k) clearances under product code KPK
ApplicantClearances
C.R. Bard Inc1
Cardio-Surgical, Inc.1
Cook Inc.1
Med-Edge, Inc.1
Scanlan Intl., Inc.1
voss medical products1

Companies listing this code with FDA

Companies whose registered establishments list this code