K070879 is an FDA 510(k) clearance for the BARD MALECOT AND PEZZER DRAINS. This device is classified as a Catheter, Malecot (Class II - Special Controls, product code FEW).
Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on April 24, 2007, 25 days after receiving the submission on March 30, 2007.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5090.
| 510(k) Number | K070879 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 2007 |
| Decision Date | April 24, 2007 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FEW — Catheter, Malecot |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5090 |