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FDA 510(k)

DUO BALLOON SYSTEM (DBS) 2 [10 AND 12 MM SIZES]

K-Number: K954174 · 1995-11-09

ApplicantOrigin Medsystems, Inc.
Decision Date1995-11-09
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DUO BALLOON SYSTEM (DBS) 2 [10 AND 12 MM SIZES] is the device name listed in this FDA 510(k) record. The listed applicant is Origin Medsystems, Inc.. It received FDA 510(k) clearance on 1995-11-09 under 510(k) number K954174. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUO BALLOON SYSTEM (DBS) 2 [10 AND 12 MM SIZES]?

DUO BALLOON SYSTEM (DBS) 2 [10 AND 12 MM SIZES] is a medical device that received FDA 510(k) clearance on 1995-11-09. The listed applicant is Origin Medsystems, Inc.. The 510(k) number is K954174.

When did DUO BALLOON SYSTEM (DBS) 2 [10 AND 12 MM SIZES] receive FDA 510(k) clearance?

DUO BALLOON SYSTEM (DBS) 2 [10 AND 12 MM SIZES] received FDA 510(k) clearance on 1995-11-09, under 510(k) number K954174.

Who is the listed applicant for DUO BALLOON SYSTEM (DBS) 2 [10 AND 12 MM SIZES]?

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

What is the FDA product code for DUO BALLOON SYSTEM (DBS) 2 [10 AND 12 MM SIZES]?

The FDA product code for DUO BALLOON SYSTEM (DBS) 2 [10 AND 12 MM SIZES] is GCJ.

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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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