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FDA 510(k)

CLIRPATH TURBO EXCIMER LASER CATHETERS

K-Number: K052296 · 2005-09-02

ApplicantSpectranetics Corp.
Decision Date2005-09-02
Product CodePDU
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CLIRPATH TURBO EXCIMER LASER CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Spectranetics Corp.. It received FDA 510(k) clearance on 2005-09-02 under 510(k) number K052296. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLIRPATH TURBO EXCIMER LASER CATHETERS?

CLIRPATH TURBO EXCIMER LASER CATHETERS is a medical device that received FDA 510(k) clearance on 2005-09-02. The listed applicant is Spectranetics Corp.. The 510(k) number is K052296.

When did CLIRPATH TURBO EXCIMER LASER CATHETERS receive FDA 510(k) clearance?

CLIRPATH TURBO EXCIMER LASER CATHETERS received FDA 510(k) clearance on 2005-09-02, under 510(k) number K052296.

Who is the listed applicant for CLIRPATH TURBO EXCIMER LASER CATHETERS?

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 CLIRPATH TURBO EXCIMER LASER CATHETERS?

The FDA product code for CLIRPATH TURBO EXCIMER LASER CATHETERS is PDU.

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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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