Cleared Traditional

K100569 - MERIT EMBOLECTOMY CATHETER MODEL ASAP100

K100569 is an FDA 510(k) clearance for MERIT EMBOLECTOMY CATHETER MODEL ASAP100, manufactured by Merit Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K100569

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.

QEZ Device Classification - Class 2, Special Controls

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 81
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K100569.
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K091703 · Concentric Medical, Inc. · Oct 2009
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K091593 · Possis Medical, Inc. · Jun 2009