The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Cook Coda Balloon Catheter.
| Device ID | K032869 |
| 510k Number | K032869 |
| Device Name: | COOK CODA BALLOON CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | COOK, INC. 750 DANIELS WAY P.O. BOX 489 Bloomington, IN 47402 |
| Contact | Theodore Heise |
| Correspondent | Theodore Heise COOK, INC. 750 DANIELS WAY P.O. BOX 489 Bloomington, IN 47402 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-15 |
| Decision Date | 2003-11-19 |
| Summary: | summary |