510(k) K183160 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge
| Applicant | Haemonetics Corporation, Braintree MA, US |
| Decision | Substantially Equivalent, May 9, 2019 |
| Received | Nov 15, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183160
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 20, 2020 | Bovie Medical Corporation Renuvion/ J-Plasma Precise Handpiece. Catalog numbers BVX-150B, BVX-270B, BVX-330B, BVX-270BPP, BVX- 330BPS, APYX-150B, APYX-270B, APYX-330B, APYX- 270BPP, and APYX-330BPS.
Product Usage: for el Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.