Cleared Traditional

K972610 - POSSIS ANGIOJET RAPID THOMBECTOMY CATHE...

K972610 is the FDA 510(k) clearance for POSSIS ANGIOJET RAPID THOMBECTOMY CATHE... by Possis Medical, Inc.. It is a Class 2 Cardiovascular device (product code QEZ) cleared through the Traditional 510(k) pathway after a 1002-day FDA review.

K972610 · Possis Medical, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2000
Decision
1002d
Days
Class 2
Risk

K972610 is an FDA 510(k) clearance for the POSSIS ANGIOJET RAPID THOMBECTOMY CATHETERS--F105 CATHETER MODEL 3030C, LF140.... Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Possis Medical, Inc. (Minneapolis, US). The FDA issued a Cleared decision on April 11, 2000 after a review of 1002 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Possis Medical, Inc. devices

Submission Details

510(k) Number K972610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1997
Decision Date April 11, 2000
Days to Decision 1002 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
877d slower than avg
Panel avg: 125d · This submission: 1002d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QEZ Aspiration Thrombectomy Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration.
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 - QEZ Aspiration Thrombectomy Catheter

All 69
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K972610.
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