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FDA 510(k)

GLADIATOR PTA BALLOON DILATION CATHETER

K-Number: K113681 · 2012-01-11

ApplicantBoston Scientific
Decision Date2012-01-11
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GLADIATOR PTA BALLOON DILATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2012-01-11 under 510(k) number K113681. 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 GLADIATOR PTA BALLOON DILATION CATHETER?

GLADIATOR PTA BALLOON DILATION CATHETER is a medical device that received FDA 510(k) clearance on 2012-01-11. The listed applicant is Boston Scientific. The 510(k) number is K113681.

When did GLADIATOR PTA BALLOON DILATION CATHETER receive FDA 510(k) clearance?

GLADIATOR PTA BALLOON DILATION CATHETER received FDA 510(k) clearance on 2012-01-11, under 510(k) number K113681.

Who is the listed applicant for GLADIATOR PTA BALLOON DILATION CATHETER?

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

What is the FDA product code for GLADIATOR PTA BALLOON DILATION CATHETER?

The FDA product code for GLADIATOR PTA BALLOON DILATION CATHETER is 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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