Cleared Traditional

K213834 - Cardio Flow Peripheral Guide Wire

K213834 is an FDA 510(k) clearance for Cardio Flow Peripheral Guide Wire, manufactured by Cardio Flow Inc.,. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K213834 · Cardio Flow Inc., · Cardiovascular device
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Mar 2022
Decision
99d
Days
Class 2
Risk

K213834 is an FDA 510(k) clearance for the Cardio Flow Peripheral Guide Wire. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Cardio Flow Inc., (Mahtomedi, US). The FDA issued a Cleared decision on March 18, 2022 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardio Flow Inc., devices

FDA 510(k) Submission Details - K213834

510(k) Number K213834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2021
Decision Date March 18, 2022
Days to Decision 99 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 125d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Quality & Regulatory Associates, LLC
Michael J Kallok

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DQX Wire, Guide, Catheter

All 541
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K213834.
FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT
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Spartan Center Wire
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R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire
K212167 · Vascular Solutions, LLC · Feb 2022
ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20
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