Submission Details
| 510(k) Number | K191237 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 08, 2019 |
| Decision Date | November 08, 2019 |
| Days to Decision | 184 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
CERENOVUS Large Bore Catheter
Nov 2019
Decision
184d
Days
Class 2
Risk
About This 510(k) Submission
K191237 is an FDA 510(k) clearance for the CERENOVUS Large Bore Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on November 8, 2019, 184 days after receiving the submission on May 8, 2019. This device falls under the Neurology 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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