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FDA 510(k)

8FR TURBO - TANDEM SYSTEM

K-Number: K112032 · 2011-10-17

ApplicantSpectranetics Corp.
Decision Date2011-10-17
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

8FR TURBO - TANDEM SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spectranetics Corp.. It received FDA 510(k) clearance on 2011-10-17 under 510(k) number K112032. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 8FR TURBO - TANDEM SYSTEM?

8FR TURBO - TANDEM SYSTEM is a medical device that received FDA 510(k) clearance on 2011-10-17. The listed applicant is Spectranetics Corp.. The 510(k) number is K112032.

When did 8FR TURBO - TANDEM SYSTEM receive FDA 510(k) clearance?

8FR TURBO - TANDEM SYSTEM received FDA 510(k) clearance on 2011-10-17, under 510(k) number K112032.

Who is the listed applicant for 8FR TURBO - TANDEM SYSTEM?

The FDA 510(k) record lists Spectranetics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 8FR TURBO - TANDEM SYSTEM?

The FDA product code for 8FR TURBO - TANDEM SYSTEM is DQY.

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Other records listing Spectranetics Corp. as applicant

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Related Devices (Code: DQY)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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