Cleared Traditional

K955551 - CARDI0METRICS FLOW WIRE XT DOPPLER GUID...

K955551 is an FDA 510(k) clearance for CARDI0METRICS FLOW WIRE XT DOPPLER GUID..., manufactured by Cardio Metrics, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K955551 · Cardio Metrics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
85d
Days
Class 2
Risk

K955551 is an FDA 510(k) clearance for the CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Cardio Metrics, Inc. (Mountain View, US). The FDA issued a Cleared decision on February 28, 1996 after a review of 85 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cardio Metrics, Inc. devices

FDA 510(k) Submission Details - K955551

510(k) Number K955551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1995
Decision Date February 28, 1996
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
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 Peers - DQX Wire, Guide, Catheter

All 541
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K955551.
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K953760 · Cordis Corp. · Nov 1995