Cleared Traditional

K013517 - 10600 DEFLECTABLE CATHETER SYSTEM

K013517 is the FDA 510(k) clearance for 10600 DEFLECTABLE CATHETER SYSTEM by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K013517 · Medtronic Vascular · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2002
Decision
185d
Days
Class 2
Risk

K013517 is an FDA 510(k) clearance for the 10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on April 25, 2002 after a review of 185 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 Medtronic Vascular devices

Submission Details

510(k) Number K013517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2001
Decision Date April 25, 2002
Days to Decision 185 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
60d slower than avg
Panel avg: 125d · This submission: 185d
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 590
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K013517.
Z3 GUIDE CATHETER
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6F MACH1/34356-XXX
K020028 · Boston Scientific · Jan 2002