Cleared Traditional

K082337 - MINNIE SUPPORT CATHETER

K082337 is an FDA 510(k) clearance for MINNIE SUPPORT CATHETER, manufactured by Vascular Solutions, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K082337 · Vascular Solutions, Inc. · Cardiovascular device
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Jan 2009
Decision
154d
Days
Class 2
Risk

K082337 is an FDA 510(k) clearance for the MINNIE SUPPORT CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Vascular Solutions, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 15, 2009 after a review of 154 days - an extended review cycle.

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. 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 Vascular Solutions, Inc. devices

FDA 510(k) Submission Details - K082337

510(k) Number K082337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2008
Decision Date January 15, 2009
Days to Decision 154 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
29d slower than avg
Panel avg: 125d · This submission: 154d
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 753
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K082337.
ASAHI CORSAIR MICROCATHETER
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K083313 · Avinger, Inc. · Feb 2009
LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM
K081878 · LeMaitre Vascular, Inc. · Jan 2009
CONQUEST PTA BALLOON DILATATION CATHETER
K083657 · C.R. Bard, Inc. · Dec 2008
CPS AIM SL SLITTABLE INNER CATHETER
K082932 · St Jude Medical · Dec 2008
CHAPERON GUIDING CATHETER
K082385 · MicroVention, Inc. · Dec 2008