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FDA 510(k)

GAZELLE BALLOON DILATATION CATHETER

K-Number: K001134 · 2000-08-31

ApplicantBoston Scientific Corp
Decision Date2000-08-31
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GAZELLE BALLOON DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2000-08-31 under 510(k) number K001134. 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 GAZELLE BALLOON DILATATION CATHETER?

GAZELLE BALLOON DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2000-08-31. The listed applicant is Boston Scientific Corp. The 510(k) number is K001134.

When did GAZELLE BALLOON DILATATION CATHETER receive FDA 510(k) clearance?

GAZELLE BALLOON DILATATION CATHETER received FDA 510(k) clearance on 2000-08-31, under 510(k) number K001134.

Who is the listed applicant for GAZELLE BALLOON DILATATION CATHETER?

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

What is the FDA product code for GAZELLE BALLOON DILATATION CATHETER?

The FDA product code for GAZELLE BALLOON DILATATION CATHETER is LIT.

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Related Devices (Code: LIT)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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