Cleared Traditional

K100569 - MERIT EMBOLECTOMY CATHETER MODEL ASAP100

K100569 is the FDA 510(k) clearance for MERIT EMBOLECTOMY CATHETER MODEL ASAP100 by Merit Medical Systems, Inc.. It is a Class 2 Cardiovascular device (product code QEZ) cleared through the Traditional 510(k) pathway after a 375-day FDA review.

K100569 · Merit Medical Systems, Inc. · Cardiovascular device
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Mar 2011
Decision
375d
Days
Class 2
Risk

K100569 is an FDA 510(k) clearance for the MERIT EMBOLECTOMY CATHETER MODEL ASAP100. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on March 11, 2011 after a review of 375 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: 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 Merit Medical Systems, Inc. devices

Submission Details

510(k) Number K100569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2010
Decision Date March 11, 2011
Days to Decision 375 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
250d slower than avg
Panel avg: 125d · This submission: 375d
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 50
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