Cleared Traditional

K922787 - ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION

K922787 is an FDA 510(k) clearance for ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCA..., manufactured by Echocath, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K922787 · Echocath, Inc. · Cardiovascular device
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Jan 1993
Decision
211d
Days
Class 2
Risk

K922787 is an FDA 510(k) clearance for the ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Echocath, Inc. (Princeton, US). The FDA issued a Cleared decision on January 6, 1993 after a review of 211 days - an extended review 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: 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 Echocath, Inc. devices

FDA 510(k) Submission Details - K922787

510(k) Number K922787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1992
Decision Date January 06, 1993
Days to Decision 211 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 125d · This submission: 211d
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 629
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K922787.
CORDIS STEERABLE GUIDEWIRE
K925833 · Cordis Corp. · Feb 1993
HI-TORQUE SPORT-T(TM) GUIDE WIRE
K915554 · Peripheral Systems Group · Feb 1993
CORDIS VIERA GUIDEWIRE
K923696 · Cordis Corp. · Feb 1993
ROADRUNNER(TM) WIRE GUIDE, MODIFICATION
K920891 · Cook, Inc. · Dec 1992
NAVIGUIDE HYDROPHILIC COATED GUIDEWIRE
K922674 · Meadox Medicals, Div. Boston Scientific Corp. · Dec 1992
TAPER GUIDEWIRES
K924987 · Target Therapeutics · Dec 1992