HydroMID 4F Single Lumen Midline Catheter

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

Access Vascular, Inc.

The following data is part of a premarket notification filed by Access Vascular, Inc. with the FDA for Hydromid 4f Single Lumen Midline Catheter.

Pre-market Notification Details

Device IDK220772
510k NumberK220772
Device Name:HydroMID 4F Single Lumen Midline Catheter
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant Access Vascular, Inc. 749 Middlesex Turnpike Billirica,  MA  01821
ContactBrian M. Hanley
CorrespondentBrian M. Hanley
Access Vascular, Inc. 749 Middlesex Turnpike Billerica,  MA  01821
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-16
Decision Date2022-12-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850030354365 K220772 000
00850030354358 K220772 000
00850030354341 K220772 000
00850030354211 K220772 000
00850030354204 K220772 000
00850030354419 K220772 000

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