The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Cerenovus Large Bore Catheter.
| Device ID | K191237 |
| 510k Number | K191237 |
| Device Name: | CERENOVUS Large Bore Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767 |
| Contact | Kirsten Franco |
| Correspondent | Kirsten Franco Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-08 |
| Decision Date | 2019-11-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886704082385 | K191237 | 000 |
| 10886704082378 | K191237 | 000 |
| 10886704082361 | K191237 | 000 |