K770835 is an FDA 510(k) clearance for the PATCH FABRIC. This device is classified as a Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (Class II - Special Controls, product code DXZ).
Submitted by Usci, Div. C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 5, 1977, 152 days after receiving the submission on May 6, 1977.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3470.
| 510(k) Number | K770835 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 1977 |
| Decision Date | October 05, 1977 |
| Days to Decision | 152 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DXZ — Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3470 |