PICC CONVENIENCE KIT— 510(k) K121990

Clearance details

Applicant

Navilyst Medical, Inc.

Product code

Code LJS

Device class

Class 2

Regulation

21 CFR 880.5970

Advisory panel

General Hospital

Date received

2012-07-06

Decision date

2012-08-03

Decision

Substantially Equivalent

Clearance type

Special

Location

Marlborough, MA, US

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Death

31

Injury

2,791

Malfunction

18,374

Other

5

Total

21,201

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-0596-2019 — BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no. 60M183481Class II·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·20181016
• Z-2200-2018 — RS TANDEM 5F DL XPP, Catalog Number 60M019881Class II·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·20180510
• Z-2201-2018 — RS 5F DL XPP, Catalog Number 60M030393Class II·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·20180510
• Z-2213-2018 — RS 5F DL XPP KIT, Catalog Number 60M183104Class II·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·20180510
• Z-2216-2018 — RS TANDEM 5F DL BIOFLO PICC, Catalog Number 60M250097Class II·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·20180510
• Z-0025-2015 — BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No. H965750231, REF/Catalog No. 75-023, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.Class II·Terminated·Navilyst Medical, Inc·20140825
• Z-0026-2015 — BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catalog No. 75-019, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media.Class II·Terminated·Navilyst Medical, Inc·20140825
• Z-0027-2015 — BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.Class II·Terminated·Navilyst Medical, Inc·20140825
• Z-0028-2015 — BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 4F-55 cm, UPN Product No. H965750121, REF/Catalog No. 75-012, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.Class II·Terminated·Navilyst Medical, Inc·20140825
• Z-0029-2015 — PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M2309831, REF/Catalog No. 60M230983, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media.Class II·Terminated·Navilyst Medical, Inc·20140825
• Z-0030-2015 — PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M1841541, REF/Catalog No. 60M184154, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801Class II·Terminated·Navilyst Medical, Inc·20140825
• Z-0031-2015 — PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M1406071, REF/Catalog No. 60M140607, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801Class II·Terminated·Navilyst Medical, Inc·20140825
• Z-0032-2015 — PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M1318471, REF/Catalog No. 60M131847, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.Class II·Terminated·Navilyst Medical, Inc·20140825
• Z-0033-2015 — PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0501981, REF/Catalog No. 60M050198, STERILE --- Intended for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media.Class II·Terminated·Navilyst Medical, Inc·20140825
• Z-0034-2015 — PICC Convenience Kit with Accessories, BioFlo Hybrid PICC, 6F-55 cm TRIPLE LUMEN, UPN Product No. H96560M0367061, REF/Catalog No. 60M036706, STERILE --- Indicated short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media.Class II·Terminated·Navilyst Medical, Inc·20140825
• Z-0035-2015 — PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M0367051, REF/Catalog No. 60M036705, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.Class II·Terminated·Navilyst Medical, Inc·20140825
• Z-0036-2015 — PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0224751, REF/Catalog No. 60M022475, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media.Class II·Terminated·Navilyst Medical, Inc·20140825

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121990.