The following data is part of a premarket notification filed by Abbott Medical with the FDA for Amplatzer Steerable Delivery Sheath.
| Device ID | K220340 |
| 510k Number | K220340 |
| Device Name: | Amplatzer Steerable Delivery Sheath |
| Classification | Catheter, Percutaneous |
| Applicant | Abbott Medical 5050 Nathan Lane N Plymouth, MN 55442 |
| Contact | Emily Jallen |
| Correspondent | Emily Jallen Abbott Medical 5050 Nathan Lane N Plymouth, MN 55442 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-07 |
| Decision Date | 2022-03-09 |