The following data is part of a premarket notification filed by Abbott (st. Jude Medical) with the FDA for Agilis Hispro Steerable Catheter With Electrodes.
| Device ID | K200721 |
| 510k Number | K200721 |
| Device Name: | Agilis HisPro Steerable Catheter With Electrodes |
| Classification | Catheter, Percutaneous |
| Applicant | Abbott (St. Jude Medical) 15900 Valley View Court Sylmar, CA 91342 |
| Contact | Winnie Yik |
| Correspondent | Winnie Yik Abbott (St. Jude Medical) 15900 Valley View Court Sylmar, CA 91342 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-19 |
| Decision Date | 2020-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067032287 | K200721 | 000 |