510(k) K180450 ยท KNW Instrument, Biopsy
Corvocet Biopsy System
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Mar 12, 2018 |
| Received | Feb 20, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180450
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 27, 2022 | Merit Medical Systems, Inc. CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/A, CORA1815/B, CORA1815S/A, CORA1815S/B, CORA1820/A, CORA1820/B, CORA1820S/A, CO Open, Classified |
KNW | None listed |
| Oct 27, 2022 | Merit Medical Systems, Inc. CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B, CORA2010S/B, CORCA1410S/B, CORCA1410S/CNB, CORCA1415S/B, CORCA1610/CNB, CORCA1615S/CNB, CORCA1810SB/CNB, CORCA18 Open, Classified |
KNW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.