510(k) K983135 ยท FQH Lavage, Jet
BLOWER/MISTER
| Applicant | Cardiothoracic Systems, Inc., Cupertino CA, US |
| Decision | Substantially Equivalent, Nov 13, 1998 |
| Received | Sep 8, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983135
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 24, 2019 | Maquet Cardiovascular, LLC AXIUS Blower Mister
Product Code/REF Number: CB-1000
The Axius Blower Mister is intended to clear an anastomotic site for improved visibility Terminated |
FQH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.