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FDA 510(k)

TALON BALLOON DILATION CATHETER

K-Number: K000798 · 2000-06-08

ApplicantBoston Scientific Corp
Decision Date2000-06-08
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TALON BALLOON DILATION 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 2000-06-08 under 510(k) number K000798. 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 TALON BALLOON DILATION CATHETER?

TALON BALLOON DILATION CATHETER is a medical device that received FDA 510(k) clearance on 2000-06-08. The listed applicant is Boston Scientific Corp. The 510(k) number is K000798.

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

TALON BALLOON DILATION CATHETER received FDA 510(k) clearance on 2000-06-08, under 510(k) number K000798.

Who is the listed applicant for TALON BALLOON DILATION 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 TALON BALLOON DILATION CATHETER?

The FDA product code for TALON 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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