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FDA 510(k)

CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH

K-Number: K120781 · 2012-08-09

ApplicantFuji Systems Corp.
Decision Date2012-08-09
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH is the device name listed in this FDA 510(k) record. The listed applicant is Fuji Systems Corp.. It received FDA 510(k) clearance on 2012-08-09 under 510(k) number K120781. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH?

CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH is a medical device that received FDA 510(k) clearance on 2012-08-09. The listed applicant is Fuji Systems Corp.. The 510(k) number is K120781.

When did CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH receive FDA 510(k) clearance?

CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH received FDA 510(k) clearance on 2012-08-09, under 510(k) number K120781.

Who is the listed applicant for CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH?

The FDA 510(k) record lists Fuji Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH?

The FDA product code for CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH is DQY.

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.

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Other records listing Fuji Systems 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.

K051522SILBRONCHO DOUBLE LUMEN TUBE

Related Devices (Code: DQY)

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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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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