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FDA 510(k)

2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011

K-Number: K043465 · 2005-08-18

ApplicantSpectranetics Corp.
Decision Date2005-08-18
Product CodePDU
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011 is the device name listed in this FDA 510(k) record. The listed applicant is Spectranetics Corp.. It received FDA 510(k) clearance on 2005-08-18 under 510(k) number K043465. 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 2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011?

2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011 is a medical device that received FDA 510(k) clearance on 2005-08-18. The listed applicant is Spectranetics Corp.. The 510(k) number is K043465.

When did 2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011 receive FDA 510(k) clearance?

2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011 received FDA 510(k) clearance on 2005-08-18, under 510(k) number K043465.

Who is the listed applicant for 2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011?

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 2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011?

The FDA product code for 2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011 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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