Cleared Traditional

K113266 - GEL-BLOCK EMBOLIZATION PLEDGETS

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

K113266 · Vascular Solutions, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K113266

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.

KRD Device Classification - Class 2, Special Controls

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 99
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K113266.
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
K122543 · MicroVention, Inc. · Nov 2012
AZUR CX DETACHABLE 18
K123384 · MicroVention, Inc. · Nov 2012
AZUR DETACHABLE 35
K122316 · MicroVention, Inc. · Aug 2012
INZONE DETACHMENT SYSTEM
K120816 · Stryker · Apr 2012
AZUR DETACHABLE 18
K120630 · MicroVention, Inc. · Mar 2012
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K113651 · Boston Scientific Corporation · Jan 2012