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FDA 510(k)

MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH

K-Number: K930623 · 1994-09-28

Decision Date1994-09-28
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH 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 1994-09-28 under 510(k) number K930623. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH?

MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH is a medical device that received FDA 510(k) clearance on 1994-09-28. The listed applicant is Boston Scientific Corp. The 510(k) number is K930623.

When did MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH receive FDA 510(k) clearance?

MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH received FDA 510(k) clearance on 1994-09-28, under 510(k) number K930623.

Who is the listed applicant for MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH?

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 INSURG BILIARY BALLOON DILATITION CATH?

The FDA product code for MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH is FGE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Boston Scientific Corp as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: FGE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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