Cleared Traditional

K101015 - GUIDE CATHETERS AND ACCESSORIES

K101015 is the FDA 510(k) clearance for GUIDE CATHETERS AND ACCESSORIES by Thomas Medical Products, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K101015 · Thomas Medical Products, Inc. · Cardiovascular device
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Sep 2010
Decision
164d
Days
Class 2
Risk

K101015 is an FDA 510(k) clearance for the GUIDE CATHETERS AND ACCESSORIES. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Thomas Medical Products, Inc. (Malvern, US). The FDA issued a Cleared decision on September 23, 2010 after a review of 164 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 Thomas Medical Products, Inc. devices

Submission Details

510(k) Number K101015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2010
Decision Date September 23, 2010
Days to Decision 164 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 125d · This submission: 164d
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 519
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