Cardio Flow Peripheral Guide Wire

Wire, Guide, Catheter

Cardio Flow, Inc.

The following data is part of a premarket notification filed by Cardio Flow, Inc. with the FDA for Cardio Flow Peripheral Guide Wire.

Pre-market Notification Details

Device IDK213834
510k NumberK213834
Device Name:Cardio Flow Peripheral Guide Wire
ClassificationWire, Guide, Catheter
Applicant Cardio Flow, Inc. 888 East Avenue Mahtomedi,  MN  55115
ContactMichael J. Kallok
CorrespondentMichael J Kallok
Quality & Regulatory Associates, LLC 888 East Evenuse Mahtomedi,  MN  55115
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-09
Decision Date2022-03-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850040691023 K213834 000

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