Cleared Traditional

K112035 - VALET MICRO CATHETER

K112035 is the FDA 510(k) clearance for VALET MICRO CATHETER by Volcano Corporation. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K112035 · Volcano Corporation · Cardiovascular device
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Jan 2012
Decision
174d
Days
Class 2
Risk

K112035 is an FDA 510(k) clearance for the VALET MICRO CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Volcano Corporation (Billerica, US). The FDA issued a Cleared decision on January 5, 2012 after a review of 174 days - an extended review cycle.

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 Volcano Corporation devices

Submission Details

510(k) Number K112035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2011
Decision Date January 05, 2012
Days to Decision 174 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
49d slower than avg
Panel avg: 125d · This submission: 174d
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 577
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K112035.
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ENVOY DISTAL ACCESS GUIDING CATHETER
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K112082 · Vascular Solutions, Inc. · Dec 2011
CLEARWAY RX NB CATHETER
K113112 · Atrium Medical Corp. · Nov 2011
RUBICON SUPPORT CATHETER
K112303 · Boston Scientific · Nov 2011