Cleared Traditional

K002707 - PVS 1400 GUIDE WITE WITH HYDROPHILIC COATING

K002707 is an FDA 510(k) clearance for PVS 1400 GUIDE WITE WITH HYDROPHILIC CO..., 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 70-day FDA review.

K002707 · Precision Vascular Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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Nov 2000
Decision
70d
Days
Class 2
Risk

K002707 is an FDA 510(k) clearance for the PVS 1400 GUIDE WITE WITH HYDROPHILIC COATING. 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 November 8, 2000 after a review of 70 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 Precision Vascular Systems, Inc. devices

FDA 510(k) Submission Details - K002707

510(k) Number K002707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2000
Decision Date November 08, 2000
Days to Decision 70 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
55d faster than avg
Panel avg: 125d · This submission: 70d
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 667
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K002707.
MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES
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HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER MS GUIDE WIRE WITH HYDROCOAT HYDRO
K002206 · Guidant Corp. · Aug 2000