Cleared Traditional

K990271 - ENDOSONICS TRAK BACK DEVICE

K990271 is an FDA 510(k) clearance for ENDOSONICS TRAK BACK DEVICE, manufactured by Endosonics Corp.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K990271 · Endosonics Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
214d
Days
Class 2
Risk

K990271 is an FDA 510(k) clearance for the ENDOSONICS TRAK BACK DEVICE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Endosonics Corp. (Rancho Cordova,, US). The FDA issued a Cleared decision on August 30, 1999 after a review of 214 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 Endosonics Corp. devices

FDA 510(k) Submission Details - K990271

510(k) Number K990271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1999
Decision Date August 30, 1999
Days to Decision 214 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
89d slower than avg
Panel avg: 125d · This submission: 214d
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 627
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K990271.
.010 SILVERSPEED HYDROPOPHILIC GUIDEWIRE, .014 SILVERSPED HYDROPHILIC GUIDEWIRE, .016 SILVERSPEED HYDROPHILIC GUIDEWI
K993257 · Micro Therapeutics, Inc. · Oct 1999
AGILITY STEERABLE GUIDEWIRE
K991646 · Cordis Neurovascular, Inc. · Sep 1999
MEDTRONIC GT2 FUSION GUIDE WIRES
K992237 · Medtronic Vascular · Sep 1999
ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE
K991898 · Microvena Corp. · Jun 1999
MODIFICATION TO ULTRA-SELECT GUIDEWIRE
K991194 · Microvena Corp. · May 1999
HI-TORQUE BALANCE TREK GUIDE WIRE
K991152 · Guidant Corp. · Apr 1999