Cleared Special

K094036 - TURBO-TANDEM SYSTEM MODEL 472-110

K094036 is an FDA 510(k) clearance for TURBO-TANDEM SYSTEM MODEL 472-110, manufactured by Spectranetics Corp.. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Special 510(k) pathway after a 26-day FDA review.

K094036 · Spectranetics Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
26d
Days
Class 2
Risk

K094036 is an FDA 510(k) clearance for the TURBO-TANDEM SYSTEM MODEL 472-110. Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Spectranetics Corp. (Colorado Springs, US). The FDA issued a Cleared decision on January 25, 2010 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4875 - 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 - K094036

510(k) Number K094036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2009
Decision Date January 25, 2010
Days to Decision 26 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
99d faster than avg
Panel avg: 125d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

MCW Device Classification - Class 2, Special Controls

Product Code MCW Catheter, Peripheral, Atherectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4875
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 - MCW Catheter, Peripheral, Atherectomy

All 75
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