510(k) K182238 ยท OWQ Reprocessed Intravascular Ultrasound Catheter
Reprocessed ViewFlex Xtra ICE Catheter
| Applicant | Stryker Sustainability Solutions, Tempe AZ, US |
| Decision | Substantially Equivalent, May 8, 2019 |
| Received | Aug 20, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182238
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 1, 2020 | Stryker Sustainability Solutions Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm, Sterile EO, Rx Only, Quantity 1, UDI: 07613327376067 Terminated |
OWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.