NMI PORT— 510(k) K122767

Clearance details

Applicant

Navilyst Medical, Inc.

Product code

Code LJT

Device class

Class 2

Regulation

21 CFR 880.5965

Advisory panel

General Hospital

Date received

2012-09-10

Decision date

2013-04-30

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Marlborough, MA, US

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• K163452 — PICC Maximal Barrier Nursing Kit2017-02-03
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• K151239 — NMI DUAL PORT II2016-06-06
• K153228 — NMI Port, NMI Port II2015-12-04
• K152069 — Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter2015-09-24

Death

234

Injury

6,468

Malfunction

5,326

Other

2

Total

12,030

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0501-2020 — 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 hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.Class II·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·20190918
• Z-0502-2020 — 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 hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.Class II·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·20190918
• Z-0503-2020 — 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 hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.Class II·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·20190918
• Z-0504-2020 — BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022Class II·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·20190918
• Z-0505-2020 — 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 hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.Class II·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·20190918
• Z-0826-2014 — 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 Number 45-017; 3) 6F/SL/Plastic Port/F, Product Number H965450200, Catalog Number 45-020; 4) 8F/SL/Plastic Port/F, Product Number H965450220, Catalog Number 45-022; 5) 8F/SL/Titanium Ports/F, Product Number H965450250, Catalog Number 45-025; 6) Plastic/6F/non-filled/non-valved, Product Number H965450290, Catalog Number 45-029; 7) Plastic/6F/filled/non-valved, Product Number H965450300, Catalog Number 45-030; 8) Plastic/8F/non-filled/non-valved, Product Number H965450310, Catalog Number 45-031; 9) Plastic/8F/filled/non-valved, Product Number H965450320, Catalog Number 45-032; 10) Plastic/6F/non-filled/valved, Product Number H965450370, Catalog Number 45-037; 11) Plastic/6F/filled/valved, Product Number H965450380, Catalog Number 45-038; 12) Plastic/8F/non-filled/valved, Product Number H965450390, Catalog Number 45-039; 13) Plastic/8F/filled/valved, Product Number H965450400, Catalog Number 45-040; 14) Titanium/6F/non-filled/valved, Product Number H965450410, Catalog Number 45-041; 15) Titanium/8F/non-filled/valved, Product Number H965450430, Catalog Number 45-043. Product Usage: ***K-Shield Port Access Infusion Set, (affected product) supplied by Kawasumi Laboratories. The K-Shield Port Access Infusion Set with High Pressure Tubing is an intravascular administration set with a non-coring Huber needle that is used to access an implanted medication port for solution infusion. This device is also indicated for injection of contrast media by a power injector only with power injectable implanted port.***NMI Port is indicated for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.Class II·Terminated·Navilyst Medical, Inc.·20131125

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122767.