Cleared Traditional

K113266 - GEL-BLOCK EMBOLIZATION PLEDGETS

K113266 is the FDA 510(k) clearance for GEL-BLOCK EMBOLIZATION PLEDGETS by Vascular Solutions, Inc.. It is a Class 2 Cardiovascular device (product code KRD) cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K113266 · Vascular Solutions, Inc. · Cardiovascular device
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May 2012
Decision
192d
Days
Class 2
Risk

K113266 is an FDA 510(k) clearance for the GEL-BLOCK EMBOLIZATION PLEDGETS. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Vascular Solutions, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 14, 2012 after a review of 192 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3300 - 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

Submission Details

510(k) Number K113266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2011
Decision Date May 14, 2012
Days to Decision 192 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
67d slower than avg
Panel avg: 125d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRD Device, Vascular, For Promoting Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3300
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 - KRD Device, Vascular, For Promoting Embolization

All 93
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K113266.
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K120816 · Stryker · Apr 2012
AZUR DETACHABLE 18
K120630 · MicroVention, Inc. · Mar 2012
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K113651 · Boston Scientific Corporation · Jan 2012