Cleared Traditional

K091750 - GUIDELINER CATHETER

K091750 is the FDA 510(k) clearance for GUIDELINER CATHETER by Vascular Solutions, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K091750 · Vascular Solutions, Inc. · Cardiovascular device
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Nov 2009
Decision
141d
Days
Class 2
Risk

K091750 is an FDA 510(k) clearance for the GUIDELINER CATHETER, MODELS 5571, 5572, 5573. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Vascular Solutions, Inc. (Minneapolis, US). The FDA issued a Cleared decision on November 4, 2009 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 K091750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2009
Decision Date November 04, 2009
Days to Decision 141 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
16d slower than avg
Panel avg: 125d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 547
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K091750.
ENVOY GUIDING CATHETERS
K093184 · Codman & Shurtleff, Inc. · Nov 2009
MODIFICATION TO MODIFIED HD GUIDE CATHETER
K092298 · Concentric Medical, Inc. · Nov 2009
HEADWAY 21 MICROCATHETER, MODEL: MC212150S
K093160 · MicroVention, Inc. · Nov 2009
PIGGYBACK WIRE CONVERTER
K090977 · Vascular Solutions, Inc. · Jun 2009
GOPHER GOLD CATHETER, MODEL 5620
K091345 · Vascular Solutions, Inc. · Jun 2009
ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER
K091527 · Cook, Inc. · Jun 2009