HydroPICC 5F Dual Lumen Catheter

Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

Access Vascular Inc

The following data is part of a premarket notification filed by Access Vascular Inc with the FDA for Hydropicc 5f Dual Lumen Catheter.

Pre-market Notification Details

Device IDK213550
510k NumberK213550
Device Name:HydroPICC 5F Dual Lumen Catheter
ClassificationCatheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Applicant Access Vascular Inc 175 Middlesex Trunpike Bedford,  MA  01730
ContactBrian Hanley
CorrespondentBrian Hanley
Access Vascular Inc 175 Middlesex Trunpike Bedford,  MA  01730
Product CodeLJS  
CFR Regulation Number880.5970 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-08
Decision Date2022-05-04

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