PICC Maximal Barrier Nursing Kit— 510(k) K163452
UnknownNavilyst Medical, Inc.
FDA 510(k) clearance K163452 for PICC Maximal Barrier Nursing Kit, Unknown on 2017-02-03. 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
- Unknown
- 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 all- K161866 — BioFlo Midline Catheter
- K151239 — NMI DUAL PORT II
- K153228 — NMI Port, NMI Port II
- K152069 — Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter
- K152409 — Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC
Adverse 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 K163452
K-number listed on FDA's recall record- Z-2217-2018 — CAN 5F DL BIOFLO PASV PICC NURSING TRAY, Catalog Number 60M700936
- Z-2221-2018 — BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-019
- Z-2222-2018 — BioFlo PICC (NV) 5FSL-55cm Maximal Barrier Nursing Kit w/ 70cm Nitinol Wire PG, Catalog Number 75-032
- Z-2223-2018 — BioFlo PICC (NV) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-033
- Z-2224-2018 — BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-038
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K163452.
Data sourced from openFDA. This site is unofficial and independent of the FDA.