Cleared Special

K013638 - MODIFICATION TO VIKING OPTIMA GUIDING C...

K013638 is the FDA 510(k) clearance for MODIFICATION TO VIKING OPTIMA GUIDING C... by Guidant Corp.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Special 510(k) pathway after a 29-day FDA review.

K013638 · Guidant Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
29d
Days
Class 2
Risk

K013638 is an FDA 510(k) clearance for the MODIFICATION TO VIKING OPTIMA GUIDING CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Guidant Corp. (Temecula, US). The FDA issued a Cleared decision on December 4, 2001 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Guidant Corp. devices

Submission Details

510(k) Number K013638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2001
Decision Date December 04, 2001
Days to Decision 29 days
Submission Type Special
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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 588
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K013638.
BARD CONQUEST PTA BALLOON DILATATION CATHETER
K014212 · C.R. Bard, Inc. · Jan 2002
NUMED MULLINS PTA CATHETER
K013601 · NuMED, Inc. · Jan 2002
ULTRA -THIN SDS BALLOON DILATATION CATHETER
K011889 · Boston Scientific Corp · Dec 2001
STENT SUPPORT GUIDE CATHETER
K010579 · Medtronic Vascular · Nov 2001
CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031
K010954 · Concentric Medical, Inc. · Oct 2001
BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER
K012913 · C.R. Bard, Inc. · Sep 2001