Cleared Traditional

GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUARDDOG OCCLUSION SYSTEM OCCLUSION GUIDEWIRE, 200 CM (K031357) - FDA 510(k) Clearance

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

K031357 · Possis Medical, Inc. · Cardiovascular device
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May 2004
Decision
384d
Days
Class 2
Risk

K031357 is an FDA 510(k) clearance for the GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUARDDOG OCCLUSION SY.... Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Possis Medical, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 18, 2004 after a review of 384 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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 Possis Medical, Inc. devices

Submission Details

510(k) Number K031357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2003
Decision Date May 18, 2004
Days to Decision 384 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
259d slower than avg
Panel avg: 125d · This submission: 384d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MJN Catheter, Intravascular Occluding, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 - MJN Catheter, Intravascular Occluding, Temporary

All 22
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K031357.
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OCCLUSION BALLOON CATHETER
K132990 · Boston Scientific Corp · Oct 2013
LDOB OCCLUSION BALLOON CATHETER
K002286 · Cook, Inc. · Mar 2001