Cleared Traditional

MICROSNARE (K925439) - FDA 510(k) Clearance

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

K925439 · Microvena Corp. · Cardiovascular device
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Sep 1993
Decision
331d
Days
Class 2
Risk

K925439 is an FDA 510(k) clearance for the MICROSNARE. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Microvena Corp. (Vadnais Heights, US). The FDA issued a Cleared decision on September 24, 1993 after a review of 331 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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. Elevated predicate reliance profile. 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 K925439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1992
Decision Date September 24, 1993
Days to Decision 331 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
206d slower than avg
Panel avg: 125d · This submission: 331d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 306
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K925439.
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K952185 · Cordis Corp. · Aug 1995
GUIDING CATHETER
K930476 · Boston Scientific Corp · Feb 1994
USCI SUPER 6 6F PTCA GUIDING CATHETER
K933019 · C.R. Bard, Inc. · Sep 1993
CORDIS 9 F GUIDING CATHETER
K925131 · Cordis Corp. · May 1993
CORDIS SHUTTLE CATHETER W/ SIDEHOLES
K921311 · Cordis Corp. · Sep 1992
VASCULAR CATHETER & WIRE GUIDES W/MEDI-COAT(TM)
K914856 · Cook, Inc. · May 1992