510(k) K172453 ยท DQX Wire, Guide, Catheter
WATCHDOG Hemostasis Valve Kit
| Applicant | Boston Scientific Corporation, Maple Grove MN, US |
| Decision | Substantially Equivalent, Nov 9, 2017 |
| Received | Aug 14, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172453
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2023 | Boston Scientific Corporation WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package) Open, Classified |
DTL | None listed |
| May 16, 2023 | Boston Scientific Corporation WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package) Open, Classified |
DTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.