The following data is part of a premarket notification filed by St. Jude Medical, Cardiac Rhythm Management Divisi with the FDA for Cps Aim Sl Slittable Inner Catheters, Models Ds2n021-59, Ds2n022-59, Ds2no23-59, Ds2n024-65, Ds2n024-65, Ds2n021-65, Ds2.
| Device ID | K090613 |
| 510k Number | K090613 |
| Device Name: | CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2 |
| Classification | Catheter, Percutaneous |
| Applicant | ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 15900 VALLEY VIEW CT. Sylmar, CA 91342 |
| Contact | Colleen Canan |
| Correspondent | Colleen Canan ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 15900 VALLEY VIEW CT. Sylmar, CA 91342 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-06 |
| Decision Date | 2009-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734218092 | K090613 | 000 |
| 05414734218085 | K090613 | 000 |
| 05414734218078 | K090613 | 000 |
| 05414734218061 | K090613 | 000 |
| 05414734218054 | K090613 | 000 |
| 05414734218047 | K090613 | 000 |
| 05414734218030 | K090613 | 000 |
| 05414734218023 | K090613 | 000 |