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

Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection

21 CFR 870.1250 / Cardiovascular
FDA source (opens on fda.gov)

NFA is the FDA product code for Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection, a class II device type, regulated under 21 CFR 870.1250. As of , FDA records hold 22 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
NFA
Device name
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
22
Ingested recalls
4

Clearances, product code NFA

By decision year
22 clearances under product code NFA with a decision year between 2001 and 2008, 2006 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code NFA by decision year
YearClearances
20011
20023
20033
20041
20053
20068
20071
20082

Applicants with the most clearances

Product code NFA
Applicants holding the most 510(k) clearances under product code NFA
ApplicantClearances
Medtronic, Inc.7
Boston Scientific Corporation4
DSM Biomedical, Inc.3
Boston Scientific Epi2
Medtronic Percusurge, Inc.2
Abbott Medical2
Percu Surge, Inc.1
Velocimed, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code