510(k) K170329 ยท QPB System, Suction, Lipoplasty For Removal
Basic, Dominant Flex
| Applicant | Modela AG, Baar, CH |
| Decision | Substantially Equivalent, Mar 24, 2017 |
| Received | Feb 2, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170329
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2020 | Medela AG Medical Technology Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing (01)07612367053921 - Product Usage: AXS Universal Aspiration Tubing is used with the Dominant Flex Surgical Suction Pump. Terminated |
BTA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.