510(k) K132914 ยท DQY Catheter, Percutaneous
ACUITY PRO LEAD DELIVERY SYSTEM
| Applicant | Boston Scientific, Maple Grove MN, US |
| Decision | Substantially Equivalent, Apr 3, 2014 |
| Received | Sep 17, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132914
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2016 | Boston Scientific Corporation Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, and 8119.
The ACUITY Pro Lead Deli Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.