Submission Details
| 510(k) Number | K112828 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 28, 2011 |
| Decision Date | October 25, 2011 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
REVIVE INTERMEDIATE CATHETER (REVIVE IC)
Oct 2011
Decision
27d
Days
Class 2
Risk
About This 510(k) Submission
K112828 is an FDA 510(k) clearance for the REVIVE INTERMEDIATE CATHETER (REVIVE IC), a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on October 25, 2011, 27 days after receiving the submission on September 28, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.
Device Classification
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
Manufacturer
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