510(k) K962495 ยท MAV Syringe, Balloon Inflation
INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)
| Applicant | Advanced Cardiovascular Systems, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Sep 12, 1996 |
| Received | Jun 26, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962495
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 11, 2022 | Abbott Vascular INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01) Open, Classified |
MAV | None listed |
| Mar 11, 2022 | Abbott Vascular Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01)
Plus 30 Priority Pack w/.115 RHV - REF 1000185-115 WPL2122279-01 (2019-03-01) Open, Classified |
MAV | None listed |
| Jul 3, 2018 | Abbott Vascular PLUS 30 PRIORITY PACK Accessory Kit
Product Usage:
Is recommended for use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters Terminated |
MAV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.