PICC Maximal Barrier Nursing Kit— 510(k) K142616
Substantially EquivalentNavilyst Medical, Inc.
FDA 510(k) clearance K142616 for PICC Maximal Barrier Nursing Kit, Substantially Equivalent on 2014-10-14. Applicant: Navilyst Medical, Inc.. Device class: 2.
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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Marlborough, MA, US
Recent devices under product code LJS
view all- K260929 — Neonav ECG Tip Location System
- K252373 — BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology +6 more
- K252792 — PM2 System with ECGuide Connector
- K243458 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301) +5 more
- K251212 — Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)
More clearances from Navilyst Medical, Inc.
view allAdverse events under product code LJS
product code LJS- Death
- 31
- Injury
- 2,791
- Malfunction
- 18,374
- Other
- 5
- Total
- 21,201
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K142616
K-number listed on FDA's recall record- Z-2189-2018 — Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818
- Z-2190-2018 — Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871
- Z-2191-2018 — Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872
- Z-2193-2018 — Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-886
- Z-2194-2018 — Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887
- Z-2196-2018 — Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved with Nitinol Guidewire PG, Catalog Number 45-895
- Z-2203-2018 — RS 5F DL BIOFLO PICC, Catalog Number 60M071831
- Z-2210-2018 — 5F DL BIOFLO PICC, Catalog Number 60M180592
- Z-0708-2017 — Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The Xcela Power Injectable PICC is 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 and nutrients; the sampling of blood; and for power injection of contrast media
- Z-0709-2017 — BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN # H965750121/Catalog No: 5018265, 2) UPN # H965750131/Catalog No:5024787, 3) UPN # H965750141/Catalog No: 5024787, 4) UPN # H965750241/Catalog No: 5020644, 5) UPN # H965750325/Catalog No: 5026458, 6) UPN # H965750355/Catalog No: 5026468 The BioFlo PICCs with ENDEXO Technology are 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; for central venous pressure monitoring and for power injection of contrast media
- Z-0710-2017 — BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog No:75-019 The BioFlo PICCs with ENDEXO and PASV Valve Technology are 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
- Z-0714-2017 — Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technology are 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. Non-Valve lumens are indicated for central venous pressure monitoring
- Z-0715-2017 — Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-019 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technology are 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. Non-Valve lumens are indicated for central venous pressure monitoring.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142616.
Data sourced from openFDA. This site is unofficial and independent of the FDA.