Cleared Special

K092396 - SPECTRANETICS QUICK CROSS EXTREME SUPPO...

K092396 is an FDA 510(k) clearance for SPECTRANETICS QUICK CROSS EXTREME SUPPO..., manufactured by Spectranetics Corp.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 30-day FDA review.

K092396 · Spectranetics Corp. · Cardiovascular device
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Sep 2009
Decision
30d
Days
Class 2
Risk

K092396 is an FDA 510(k) clearance for the SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Spectranetics Corp. (Colorado Springs, US). The FDA issued a Cleared decision on September 4, 2009 after a review of 30 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 Spectranetics Corp. devices

FDA 510(k) Submission Details - K092396

510(k) Number K092396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2009
Decision Date September 04, 2009
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 619
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K092396.
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K091750 · Vascular Solutions, Inc. · Nov 2009
TRAILBLAZER SUPPORT CATHETER
K092299 · Ev3, Inc. · Aug 2009
SPECTRANETICS TURBO-TANDEM SYSTEM
K091299 · Spectranetics Corp. · Jul 2009
PIGGYBACK WIRE CONVERTER
K090977 · Vascular Solutions, Inc. · Jun 2009