The following data is part of a premarket notification filed by Abbott Medical with the FDA for Cps Aim Universal Ii Slittable Inner Catheter.
| Device ID | K221750 |
| 510k Number | K221750 |
| Device Name: | CPS AIM Universal II Slittable Inner Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91342 |
| Contact | Indira Verdekel |
| Correspondent | Indira Verdekel Abbott Medical 15900 Valley View Court 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 | 2022-06-16 |
| Decision Date | 2022-06-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067041777 | K221750 | 000 |
| 05415067041760 | K221750 | 000 |
| 05415067041753 | K221750 | 000 |
| 05415067041746 | K221750 | 000 |
| 05415067041739 | K221750 | 000 |
| 05415067041586 | K221750 | 000 |
| 05415067041524 | K221750 | 000 |
| 05415067041517 | K221750 | 000 |