FDA product code NFA: Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
NFA is the FDA product code for temporary coronary saphenous vein bypass graft for embolic protection. It is a Class II device, regulated under 21 CFR 870.1250 and reviewed by the Cardiovascular panel. FDA has cleared 22 510(k) submissions under NFA, from 10 different applicants. The average 510(k) review took 139 days (median 84). FDA has posted 4 recalls for NFA devices.
Classification
| Field | Value |
|---|---|
| Device name | Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection |
| Device class | Class II |
| Regulation | 21 CFR 870.1250 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NFA clearance
Top NFA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boston Scientific Corp | 4 | 2006-08-11 |
| Ev3, Inc. | 3 | 2007-01-19 |
| Kensey Nash Corp. | 3 | 2006-10-20 |
| Medtronic Vascular | 3 | 2003-03-26 |
| St Jude Medical | 2 | 2008-01-31 |
5 more applicants have NFA clearances. See the full list in Caduvo.
Most recent NFA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K073523 | Medtronic, Inc. | INTERCEPTOR PLUS CORONARY FILTER SYSTEMS | 2008-08-01 | 231 |
| K073563 | St Jude Medical | MODIFICATION TO PROXIS SYSTEM | 2008-01-31 | 43 |
| K063785 | Ev3, Inc. | SPIDERFX EMBOLIC PROTECTION DEVICE | 2007-01-19 | 29 |
| K062870 | Kensey Nash Corp. | TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 | 2006-10-20 | 25 |
| K060651 | St Jude Medical | PROXIS SYSTEM, MODEL EPS101 | 2006-09-13 | 184 |
Recalls for NFA devices
4 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2006-05-24.
Frequently asked questions
What is FDA product code NFA?
NFA is the FDA product code for temporary coronary saphenous vein bypass graft for embolic protection. It is a Class II device, regulated under 21 CFR 870.1250 and reviewed by the Cardiovascular panel.
What device class is NFA?
Class II, regulation 21 CFR 870.1250. Typical premarket route: 510(k).
How long does a 510(k) take for product code NFA?
Across 22 cleared submissions the average was 139 days from receipt to decision (median 84).
Which companies have the most NFA clearances?
Boston Scientific Corp (4); Ev3, Inc. (3); Kensey Nash Corp. (3); Medtronic Vascular (3); St Jude Medical (2).
Have NFA devices been recalled?
Yes: 4 product recalls across 2 recall events; the most recent began 2006-05-24.
Next steps
- Run an FDA pathway report with predicate devices for product code NFA
- Run a recall and safety report across every NFA manufacturer
- Watch product code NFA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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