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FDA 510(k)

XXL BALLON DILATATION CATHETER

K-Number: K952063 · 1995-11-14

ApplicantBoston Scientific Corp
Decision Date1995-11-14
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

XXL BALLON 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 1995-11-14 under 510(k) number K952063. 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 XXL BALLON DILATATION CATHETER?

XXL BALLON DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 1995-11-14. The listed applicant is Boston Scientific Corp. The 510(k) number is K952063.

When did XXL BALLON DILATATION CATHETER receive FDA 510(k) clearance?

XXL BALLON DILATATION CATHETER received FDA 510(k) clearance on 1995-11-14, under 510(k) number K952063.

Who is the listed applicant for XXL BALLON 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 XXL BALLON DILATATION CATHETER?

The FDA product code for XXL BALLON DILATATION 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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