510(k) K122767 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
NMI PORT
| Applicant | Navilyst Medical, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, Apr 30, 2013 |
| Received | Sep 10, 2012 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K122767
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2019 | Angiodynamics Inc. (Navilyst Medical Inc.) BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hy Terminated |
LJT | None listed |
| Sep 18, 2019 | Angiodynamics Inc. (Navilyst Medical Inc.) BIOFLO 8F SINGLE TITANIUM NON- FILLED; VALVED, UPN H965440250, Cat. No. 44-025 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to Terminated |
LJT | None listed |
| Sep 18, 2019 | Angiodynamics Inc. (Navilyst Medical Inc.) BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED, UPN H965440210, Cat. No. 44-021 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hy Terminated |
LJT | None listed |
| Sep 18, 2019 | Angiodynamics Inc. (Navilyst Medical Inc.) BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022 Terminated |
LJT | None listed |
| Sep 18, 2019 | Angiodynamics Inc. (Navilyst Medical Inc.) XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat. No. 44-040 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to h 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.