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FDA 510(k)

BOLTON PTA CATHETER

K-Number: K021996 · 2002-08-23

ApplicantBolton Medical, Inc.
Decision Date2002-08-23
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BOLTON PTA CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Bolton Medical, Inc.. It received FDA 510(k) clearance on 2002-08-23 under 510(k) number K021996. 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 BOLTON PTA CATHETER?

BOLTON PTA CATHETER is a medical device that received FDA 510(k) clearance on 2002-08-23. The listed applicant is Bolton Medical, Inc.. The 510(k) number is K021996.

When did BOLTON PTA CATHETER receive FDA 510(k) clearance?

BOLTON PTA CATHETER received FDA 510(k) clearance on 2002-08-23, under 510(k) number K021996.

Who is the listed applicant for BOLTON PTA CATHETER?

The FDA 510(k) record lists Bolton Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOLTON PTA CATHETER?

The FDA product code for BOLTON PTA CATHETER is 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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