FDA product code NMF: Clamp, Vascular, Reprocessed
NMF is the FDA product code for clamp, vascular, reprocessed. It is a Class II device, regulated under 21 CFR 870.4450 and reviewed by the Cardiovascular panel. FDA has cleared 3 510(k) submissions under NMF, from 2 different applicants. The average 510(k) review took 202 days (median 192). FDA has posted 2 recalls for NMF devices.
Definition
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Classification
| Field | Value |
|---|---|
| Device name | Clamp, Vascular, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 870.4450 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NMF clearance
Top NMF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sterilmed, Inc. | 2 | 2012-04-03 |
| Vanguard Medical Concepts, Inc. | 1 | 2001-12-21 |
Most recent NMF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K120204 | Sterilmed, Inc. | REPROCESSED FEMORAL COMPRESSION DEVICE | 2012-04-03 | 71 |
| K012574 | Sterilmed, Inc. | REPROCESSED FEMORAL COMPRESSION DEVICE | 2002-07-18 | 343 |
| K011832 | Vanguard Medical Concepts, Inc. | VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE | 2001-12-21 | 192 |
Recalls for NMF devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-06-23.
Frequently asked questions
What is FDA product code NMF?
NMF is the FDA product code for clamp, vascular, reprocessed. It is a Class II device, regulated under 21 CFR 870.4450 and reviewed by the Cardiovascular panel.
What device class is NMF?
Class II, regulation 21 CFR 870.4450. Typical premarket route: 510(k).
How long does a 510(k) take for product code NMF?
Across 3 cleared submissions the average was 202 days from receipt to decision (median 192).
Which companies have the most NMF clearances?
Sterilmed, Inc. (2); Vanguard Medical Concepts, Inc. (1).
Have NMF devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2010-06-23.
Next steps
- Run an FDA pathway report with predicate devices for product code NMF
- Run a recall and safety report across every NMF manufacturer
- Watch product code NMF 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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