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FDA 510(k)

Vassallo GT 018 Hybrid

K-Number: K223432 · 2023-03-09

ApplicantFilmecc Co., Ltd.
Decision Date2023-03-09
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vassallo GT 018 Hybrid 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 2023-03-09 under 510(k) number K223432. 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 018 Hybrid?

Vassallo GT 018 Hybrid is a medical device that received FDA 510(k) clearance on 2023-03-09. The listed applicant is Filmecc Co., Ltd.. The 510(k) number is K223432.

When did Vassallo GT 018 Hybrid receive FDA 510(k) clearance?

Vassallo GT 018 Hybrid received FDA 510(k) clearance on 2023-03-09, under 510(k) number K223432.

Who is the listed applicant for Vassallo GT 018 Hybrid?

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 018 Hybrid?

The FDA product code for Vassallo GT 018 Hybrid 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.

K222631VASSALLO GT EXTK213949VASSALLO 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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