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FDA 510(k)

VASSALLO GT EXT

K-Number: K222631 · 2022-10-26

ApplicantFilmecc Co., Ltd.
Decision Date2022-10-26
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VASSALLO GT EXT is the device name listed in this FDA 510(k) record. The listed applicant is Filmecc Co., Ltd.. It received FDA 510(k) clearance on 2022-10-26 under 510(k) number K222631. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VASSALLO GT EXT?

VASSALLO GT EXT is a medical device that received FDA 510(k) clearance on 2022-10-26. The listed applicant is Filmecc Co., Ltd.. The 510(k) number is K222631.

When did VASSALLO GT EXT receive FDA 510(k) clearance?

VASSALLO GT EXT received FDA 510(k) clearance on 2022-10-26, under 510(k) number K222631.

Who is the listed applicant for VASSALLO GT EXT?

The FDA 510(k) record lists Filmecc Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VASSALLO GT EXT?

The FDA product code for VASSALLO GT EXT is DQX.

Other records listing Filmecc Co., Ltd. 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.

K223432Vassallo GT 018 HybridK213949VASSALLO GT 018 FloppyK203529VASSALLO GT HybridK203533VASSALLO GT

Related Devices (Code: DQX)

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.

K253667Accoat Guide WireSp Medical A/SK261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., Ltd.K253746Enroute 0.014'' Transcarotid GuidewireLake Region MedicalK253262EmeryGlide™ (EG18008901)Nano4imaging GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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