Cleared Traditional

K954642 - HYDRO-SELECT GUIDEWIRE

K954642 is an FDA 510(k) clearance for HYDRO-SELECT GUIDEWIRE, manufactured by Microvena Corp.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 434-day FDA review.

K954642 · Microvena Corp. · Cardiovascular device
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Dec 1996
Decision
434d
Days
Class 2
Risk

K954642 is an FDA 510(k) clearance for the HYDRO-SELECT GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Microvena Corp. (White Bear Lake, US). The FDA issued a Cleared decision on December 17, 1996 after a review of 434 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Microvena Corp. devices

FDA 510(k) Submission Details - K954642

510(k) Number K954642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1995
Decision Date December 17, 1996
Days to Decision 434 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
309d slower than avg
Panel avg: 125d · This submission: 434d
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 617
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K954642.
TORQUE DEVICE
K964352 · B.Braun Medical, Inc. · Jan 1997
TRANSEND GUIDEWIRE
K964611 · Boston Scientific Corp · Jan 1997
ACS HI-TORQUE IRON MAN GUIDE WIRE
K963702 · Advanced Cardiovascular Systems, Inc. · Jan 1997
SCIMED CHOICE PT VISION PTCA GUIDE WIRE
K962572 · Scimed Life Systems, Inc. · Dec 1996
MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX)
K961917 · Medtronics Interventional Vascular · Nov 1996
CORDIS ST STEERABLE GUIDEWIRE
K963214 · Cordis Corp. · Nov 1996