Submission Details
| 510(k) Number | K122306 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 01, 2012 |
| Decision Date | March 08, 2013 |
| Days to Decision | 219 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
SYNOVIS COLLAGEN MATRIX (TBD)
Mar 2013
Decision
219d
Days
Class 2
Risk
About This 510(k) Submission
K122306 is an FDA 510(k) clearance for the SYNOVIS COLLAGEN MATRIX (TBD), a Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (Class II — Special Controls, product code DXZ), submitted by Synovis Surgical Innovations (St. Paul, US). The FDA issued a Cleared decision on March 8, 2013, 219 days after receiving the submission on August 1, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3470.
Device Classification
| Product Code | DXZ — Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.3470 |
Manufacturer
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