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FDA 510(k)

CHANNEL BALLOON CATHETER

K-Number: K970379 · 1997-05-01

ApplicantBoston Scientific Corp
Decision Date1997-05-01
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CHANNEL BALLOON 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 1997-05-01 under 510(k) number K970379. 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 CHANNEL BALLOON CATHETER?

CHANNEL BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 1997-05-01. The listed applicant is Boston Scientific Corp. The 510(k) number is K970379.

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

CHANNEL BALLOON CATHETER received FDA 510(k) clearance on 1997-05-01, under 510(k) number K970379.

Who is the listed applicant for CHANNEL BALLOON 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 CHANNEL BALLOON CATHETER?

The FDA product code for CHANNEL BALLOON 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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