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FDA 510(k)

CORDIS SLALOM PTA BALLOON CATHETER

K-Number: K003159 · 2000-10-30

ApplicantCordis Corp.
Decision Date2000-10-30
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CORDIS SLALOM PTA BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 2000-10-30 under 510(k) number K003159. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORDIS SLALOM PTA BALLOON CATHETER?

CORDIS SLALOM PTA BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 2000-10-30. The listed applicant is Cordis Corp.. The 510(k) number is K003159.

When did CORDIS SLALOM PTA BALLOON CATHETER receive FDA 510(k) clearance?

CORDIS SLALOM PTA BALLOON CATHETER received FDA 510(k) clearance on 2000-10-30, under 510(k) number K003159.

Who is the listed applicant for CORDIS SLALOM PTA BALLOON CATHETER?

The FDA 510(k) record lists Cordis Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORDIS SLALOM PTA BALLOON CATHETER?

The FDA product code for CORDIS SLALOM PTA BALLOON CATHETER is LIT.

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Related Devices (Code: LIT)

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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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