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FDA 510(k)

2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035

K-Number: K123632 · 2013-01-25

ApplicantSpectranetics Corp.
Decision Date2013-01-25
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035 is the device name listed in this FDA 510(k) record. The listed applicant is Spectranetics Corp.. It received FDA 510(k) clearance on 2013-01-25 under 510(k) number K123632. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035?

2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035 is a medical device that received FDA 510(k) clearance on 2013-01-25. The listed applicant is Spectranetics Corp.. The 510(k) number is K123632.

When did 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035 receive FDA 510(k) clearance?

2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035 received FDA 510(k) clearance on 2013-01-25, under 510(k) number K123632.

Who is the listed applicant for 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035?

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 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035?

The FDA product code for 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035 is MCW.

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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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