510(k) K220340 ยท DQY Catheter, Percutaneous
Amplatzer Steerable Delivery Sheath
| Applicant | ABBOTT MEDICAL, Plymouth MN, US |
| Decision | Substantially Equivalent, Mar 9, 2022 |
| Received | Feb 7, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K220340
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2023 | Abbott Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac). Open, Classified |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.