Cleared Traditional

K925439 - MICROSNARE

K925439 is an FDA 510(k) clearance for MICROSNARE, manufactured by Microvena Corp.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 331-day FDA review.

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

FDA 510(k) Submission Details - K925439

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
Combination Product No
PCCP Authorized No
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.

DQY Device Classification - Class 2, Special Controls

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 663
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K925439.
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K933033 · Arrow Intl., Inc. · Sep 1993
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K932619 · Thomas Medical Products, Inc. · Aug 1993
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K925131 · Cordis Corp. · May 1993