K012574 is an FDA 510(k) clearance for the REPROCESSED FEMORAL COMPRESSION DEVICE. This device is classified as a Clamp, Vascular, Reprocessed (Class II - Special Controls, product code NMF).
Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on July 18, 2002, 343 days after receiving the submission on August 9, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450. 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)..
| 510(k) Number | K012574 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 2001 |
| Decision Date | July 18, 2002 |
| Days to Decision | 343 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | NMF — Clamp, Vascular, Reprocessed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4450 |
| 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). |