Cleared Traditional

K990823 - PVS 1400 GUIDEWIRE

K990823 is an FDA 510(k) clearance for PVS 1400 GUIDEWIRE, manufactured by Precision Vascular Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K990823 · Precision Vascular Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
133d
Days
Class 2
Risk

K990823 is an FDA 510(k) clearance for the PVS 1400 GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Precision Vascular Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on July 23, 1999 after a review of 133 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 Precision Vascular Systems, Inc. devices

FDA 510(k) Submission Details - K990823

510(k) Number K990823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1999
Decision Date July 23, 1999
Days to Decision 133 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
8d slower than avg
Panel avg: 125d · This submission: 133d
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 666
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K990823.
AGILITY STEERABLE GUIDEWIRE
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K992237 · Medtronic Vascular · Sep 1999
ENDOSONICS TRAK BACK DEVICE
K990271 · Endosonics Corp. · Aug 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