510(k) K151373 ยท FCG Biopsy Needle
Corvocet Coaxial Introducer
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Aug 7, 2015 |
| Received | May 21, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151373
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office MERIT MEDICAL SYSTEMS Temno Soft Tissue Biopsy Device Temno 14 Gauge 6 cm Length Beveled Sharp Tip
Model Number: T146 Open, Classified |
FCG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.