Cleared Traditional

K081846 - GREBSET MICRO-INTRODUCER KIT

K081846 is the FDA 510(k) clearance for GREBSET MICRO-INTRODUCER KIT by Vascular Solutions, Inc.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K081846 · Vascular Solutions, Inc. · Cardiovascular device
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Jan 2009
Decision
212d
Days
Class 2
Risk

K081846 is an FDA 510(k) clearance for the GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Vascular Solutions, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 28, 2009 after a review of 212 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 K081846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2008
Decision Date January 28, 2009
Days to Decision 212 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
87d slower than avg
Panel avg: 125d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 269
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K081846.
MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047
K091961 · Concentric Medical, Inc. · Jul 2009
ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM
K090276 · Siemens Medical Solutions USA, Inc. · Feb 2009
RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)
K090040 · Terumo Medical Corp. · Feb 2009
RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER
K082736 · Terumo Medical Corp. · Sep 2008
INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, 7903, 7904 AND 7905
K073585 · Vascular Solutions, Inc. · Apr 2008
GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582
K073200 · Vascular Solutions, Inc. · Feb 2008