510(k) K961471 ยท MAV Syringe, Balloon Inflation
INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)
| Applicant | Advanced Cardiovascular Systems, Inc., Santa Clara CA, US |
| Decision | Unknown, May 8, 1996 |
| Received | Apr 17, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961471
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2024 | Abbott Vascular Inc 20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation catheters to create and monitor pressure in the balloon. Open, Classified |
MAV | None listed |
| Dec 20, 2024 | Abbott Vascular Inc 20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherect Open, Classified |
MAV | None listed |
| Dec 20, 2024 | Abbott Vascular Inc 20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures. Open, Classified |
MAV | None listed |
| Dec 20, 2024 | Abbott Vascular Inc 20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures. Open, Classified |
MAV | None listed |
| Mar 11, 2022 | Abbott Vascular 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01) Open, Classified |
MAV | None listed |
| Mar 11, 2022 | Abbott Vascular 20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01)
20/30 Priority Pack w/.115 RHV - REF 1000186-115 WPL2122270-02 (2019-03-01) Open, Classified |
MAV | None listed |
| Mar 11, 2022 | Abbott Vascular 20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01) Open, Classified |
MAV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.