FDA.reportPublic FDA data

CARDIO FLOW, INC.

Matched from indexed company URL: Cardio Flow, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30151246943015124694CARDIO FLOW, INC.1N2026-01-013530 88th Ave NE Blaine MN US 55014

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850040691009Cardio Flow Peripheral Guide Wire - Cardio Flow Peripheral Guide Wire Guidewire, 325 CM800-294-5517customerservice@cardioflow.net
00850040691023Cardio Flow Peripheral Guide Wire - Cardio Flow Peripheral Guide Wire Guidewire, 325 CM800-294-5517customerservice@cardioflow.net
00850040691030FreedomFlow Orbital Circumferential Atherectomy System - FreedomFlow Orbital Circumferential Atherectomy System Electric User Handle, 5Fr 150 cm, 5-sphere800-294-5517customerservice@cardioflow.net
00850040691054FreedomFlow Orbital Circumferential Atherectomy System - FreedomFlow Orbital Circumferential Atherectomy System Electric User Handle, 6Fr 135 cm, 5-sphere800-294-5517customerservice@cardioflow.net

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3039772034483661K231538FreedomFlow Orbital Circumferential Atherectomy SystemMCW2023-09-27
3039771927496766K213834Cardio Flow Peripheral Guide WireDQX2022-03-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MCW12023-09-27
DQX12022-03-18

PMN#

iTFlow

2023-05-12

Cardio Flow Design, Inc.

GUDID#