FDA 510(k)

MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER

K-Number: K931619 · 1993-08-20

Decision Date1993-08-20

Product CodeGCA

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

MICROVASIVE EXTRACTOR, RETRIEVAL 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 1993-08-20 under 510(k) number K931619. The device is classified under product code GCA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER?

MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 1993-08-20. The listed applicant is Boston Scientific Corp. The 510(k) number is K931619.

When did MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER receive FDA 510(k) clearance?

MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER received FDA 510(k) clearance on 1993-08-20, under 510(k) number K931619.

Who is the listed applicant for MICROVASIVE EXTRACTOR, RETRIEVAL 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 MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER?

The FDA product code for MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER is GCA.

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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.