510(k) K131694 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
NMI PORT II CATHETER
| Applicant | Navilyst Medical, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, Aug 8, 2013 |
| Received | Jun 10, 2013 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K131694
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210 Catalog Number: 44-021
Box of 1 Port - Product Usage - Long-term access to the Terminated |
LJT | None listed |
| Jan 24, 2014 | Navilyst Medical, Inc. Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalog Number 45-014;
2) 8F/SL/Titanium Ports/NF, Product Number H965450170, Catalog Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.