Clamp, Vascular, Reprocessed
FDA product code NMF · Class II (moderate risk) · 21 CFR 870.4450 · Cardiovascular
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).
3510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K120204 | Reprocessed Femoral Compression DeviceNMF · Traditional | Sterilmed, Inc. | 04/03/2012SE |
| K012574 | Reprocessed Femoral Compression DeviceNMF · Traditional | Sterilmed, Inc. | 07/18/2002SE |
| K011832 | Vanguard Reprocessed Femoral Compression DeviceNMF · Traditional | Vanguard Medical Concepts, Inc. | 12/21/2001SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2196-2010 | ASCENT HEALTHCARE SOLUTIONS. Reprocessed Femoral Compression Device, Model 11165.The FemoStop Devices may fail to inflate or hold pressure. A separation between the dome and arch base… | Ascent Healthcare Solutions, Inc. | 06/23/2010Terminated |
| Z-0557-2009 | Femoral Compression Device Model #'s: RAD11163 Intended for use in the compression of…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | Sterilmed Inc | 08/08/2008Terminated |