The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Cps Aim Inner Catheter, Models 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148.
| Device ID | K053217 |
| 510k Number | K053217 |
| Device Name: | CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148 |
| Classification | Catheter, Percutaneous |
| Applicant | ST. JUDE MEDICAL 15900 VALLEY VIEW CT. Sylmar, CA 91342 -3577 |
| Contact | Deanna Hughes |
| Correspondent | Deanna Hughes ST. JUDE MEDICAL 15900 VALLEY VIEW CT. Sylmar, CA 91342 -3577 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-17 |
| Decision Date | 2006-03-08 |
| Summary: | summary |