Cleared Traditional

K091299 - SPECTRANETICS TURBO-TANDEM SYSTEM

K091299 is an FDA 510(k) clearance for SPECTRANETICS TURBO-TANDEM SYSTEM, manufactured by Spectranetics Corp.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K091299 · Spectranetics Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
58d
Days
Class 2
Risk

K091299 is an FDA 510(k) clearance for the SPECTRANETICS TURBO-TANDEM SYSTEM. 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 July 1, 2009 after a review of 58 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Spectranetics Corp. devices

FDA 510(k) Submission Details - K091299

510(k) Number K091299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2009
Decision Date July 01, 2009
Days to Decision 58 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
67d faster than avg
Panel avg: 125d · This submission: 58d
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 619
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K091299.
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GOPHER GOLD CATHETER, MODEL 5620
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K091527 · Cook, Inc. · Jun 2009