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ACCESS VASCULAR, INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30215706453021570645ACCESS VASCULAR, INC1N2026-01-01749 Middlesex Turnpike Billerica MA US 01821
30150602323015060232ACCESS VASCULAR, INC1N2020-04-25175 Middlesex Turnpike Bedford MA US 01730

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3024331245117215K244059HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104)FOZ2025-03-27
3024331732983007K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); HydrLJS2025-08-01
3024331503527291K220772HydroMID 4F Single Lumen Midline CatheterFOZ2022-12-07
3024331502499980K213550HydroPICC 5F Dual Lumen CatheterLJS2022-05-04
3024331741849928K203069HydroMIDFOZ2021-02-08
2230481524319324K193015HydroPICC (PICC-142)LJS2020-02-20
3024331524319324K193015HydroPICC (PICC-142)LJS2020-02-20

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LJS42025-08-01
FOZ32025-03-27

PMN#

GUDID#

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