Cleared Traditional

K091750 - GUIDELINER CATHETER, MODELS 5571, 5572, 5573

K091750 is an FDA 510(k) clearance for GUIDELINER CATHETER, manufactured by Vascular Solutions, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K091750

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.

DQY Device Classification - Class 2, Special Controls

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 724
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
SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS
K092396 · Spectranetics Corp. · Sep 2009
TRAILBLAZER SUPPORT CATHETER
K092299 · Ev3, Inc. · Aug 2009
SPECTRANETICS TURBO-TANDEM SYSTEM
K091299 · Spectranetics Corp. · Jul 2009