Cleared Traditional

K033670 - GORE TRI-LOBE BALLOON CATHETER

K033670 is an FDA 510(k) clearance for GORE TRI-LOBE BALLOON CATHETER, manufactured by W.L. Gore & Associates, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K033670 · W.L. Gore & Associates, Inc. · Cardiovascular device
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May 2004
Decision
163d
Days
Class 2
Risk

K033670 is an FDA 510(k) clearance for the GORE TRI-LOBE BALLOON CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on May 5, 2004 after a review of 163 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 W.L. Gore & Associates, Inc. devices

FDA 510(k) Submission Details - K033670

510(k) Number K033670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2003
Decision Date May 05, 2004
Days to Decision 163 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
38d slower than avg
Panel avg: 125d · This submission: 163d
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 803
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K033670.
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NUMED MULLINS X PTA CATHETER
K041093 · NuMED, Inc. · May 2004
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K033875 · Cook, Inc. · Apr 2004
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K040481 · Intra Luminal Therapeutics, Inc. · Mar 2004
SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034, 518-035, 518-036, 518-037 AND 518-038
K033678 · Spectranetics Corp. · Feb 2004