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FDA 510(k)

SPECTRANETICS TURBO-TANDEM SYSTEM

K-Number: K091299 · 2009-07-01

ApplicantSpectranetics Corp.
Decision Date2009-07-01
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPECTRANETICS 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 2009-07-01 under 510(k) number K091299. 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 SPECTRANETICS TURBO-TANDEM SYSTEM?

SPECTRANETICS TURBO-TANDEM SYSTEM is a medical device that received FDA 510(k) clearance on 2009-07-01. The listed applicant is Spectranetics Corp.. The 510(k) number is K091299.

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

SPECTRANETICS TURBO-TANDEM SYSTEM received FDA 510(k) clearance on 2009-07-01, under 510(k) number K091299.

Who is the listed applicant for SPECTRANETICS 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 SPECTRANETICS TURBO-TANDEM SYSTEM?

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

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Other records listing Spectranetics Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K1236322.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035K1120328FR TURBO - TANDEM SYSTEMK093257TORQMAX SHEATH GRIP ACCESSORYK094036TURBO-TANDEM SYSTEM MODEL 472-110K092378SPECTRANETICS VISISHEATH DILATOR SHEATHK092396SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS

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Related Devices (Code: DQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

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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