Cleared Traditional

M-PATH NITINOL GUIDEWIRE (K946356) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K946356 · Microvena Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
91d
Days
Class 2
Risk

K946356 is an FDA 510(k) clearance for the M-PATH NITINOL 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 March 31, 1995 after a review of 91 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 Microvena Corp. devices

Submission Details

510(k) Number K946356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1994
Decision Date March 31, 1995
Days to Decision 91 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 125d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 227
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K946356.
PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING
K945379 · Boston Scientific Corp · Jun 1995
PRECEDER GUIDEWIRE
K950352 · Boston Scientific Corp · Apr 1995
CORDIS STEERABLE GUIDEWIRES
K950316 · Cordis Corp. · Apr 1995
THE PROMPT GUIDWIRE
K943522 · Cordis Corp. · Dec 1994
GUIDE WIRE
K942453 · Boston Scientific Corp · Dec 1994
CORDIS STEERABLE GUIDEWIRE
K943340 · Cordis Corp. · Sep 1994