Atlas FDA

NMI PICC MAXIMAL BARRIER NURSING KITS

FDA 510(k) clearance K131038 · decided 2013-05-09

Clearance details

K-number
K131038
Device name
NMI PICC MAXIMAL BARRIER NURSING KITS
Applicant
Navilyst Medical, Inc.
Decision
Substantially Equivalent
Date received
2013-04-15
Decision date
2013-05-09
Days to decision
24 days
Clearance type
Special
Product code
LJS
Device class
2
Regulation number
880.5970
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Marlborough, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No. recall (Z-0025-2015)Navilyst Medical, Inc2014-10-07
BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, recall (Z-0026-2015)Navilyst Medical, Inc2014-10-07
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. recall (Z-0027-2015)Navilyst Medical, Inc2014-10-07
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 4F-55 cm, UPN Product No. recall (Z-0028-2015)Navilyst Medical, Inc2014-10-07
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, recall (Z-0029-2015)Navilyst Medical, Inc2014-10-07
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, recall (Z-0030-2015)Navilyst Medical, Inc2014-10-07
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, recall (Z-0031-2015)Navilyst Medical, Inc2014-10-07
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL L recall (Z-0032-2015)Navilyst Medical, Inc2014-10-07
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, recall (Z-0033-2015)Navilyst Medical, Inc2014-10-07
PICC Convenience Kit with Accessories, BioFlo Hybrid PICC, 6F-55 cm TRIPLE LUMEN, UPN Prod recall (Z-0034-2015)Navilyst Medical, Inc2014-10-07
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL L recall (Z-0035-2015)Navilyst Medical, Inc2014-10-07
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, recall (Z-0036-2015)Navilyst Medical, Inc2014-10-07