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FDA 510(k)

CLIRPATH EXCIMER LASER CATHETER

K-Number: K040067 · 2004-04-27

ApplicantSpectranetics Corp.
Decision Date2004-04-27
Product CodePDU
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CLIRPATH EXCIMER LASER CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Spectranetics Corp.. It received FDA 510(k) clearance on 2004-04-27 under 510(k) number K040067. 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 EXCIMER LASER CATHETER?

CLIRPATH EXCIMER LASER CATHETER is a medical device that received FDA 510(k) clearance on 2004-04-27. The listed applicant is Spectranetics Corp.. The 510(k) number is K040067.

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

CLIRPATH EXCIMER LASER CATHETER received FDA 510(k) clearance on 2004-04-27, under 510(k) number K040067.

Who is the listed applicant for CLIRPATH EXCIMER LASER CATHETER?

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 EXCIMER LASER CATHETER?

The FDA product code for CLIRPATH EXCIMER LASER CATHETER 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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