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FDA 510(k)

VASSALLO GT 018 G12; VASSALLO GT 018 G30

K-Number: K232578 · 2023-10-11

ApplicantFilmec Co. , Ltd.
Decision Date2023-10-11
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VASSALLO GT 018 G12; VASSALLO GT 018 G30 is the device name listed in this FDA 510(k) record. The listed applicant is Filmec Co. , Ltd.. It received FDA 510(k) clearance on 2023-10-11 under 510(k) number K232578. 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 G12; VASSALLO GT 018 G30?

VASSALLO GT 018 G12; VASSALLO GT 018 G30 is a medical device that received FDA 510(k) clearance on 2023-10-11. The listed applicant is Filmec Co. , Ltd.. The 510(k) number is K232578.

When did VASSALLO GT 018 G12; VASSALLO GT 018 G30 receive FDA 510(k) clearance?

VASSALLO GT 018 G12; VASSALLO GT 018 G30 received FDA 510(k) clearance on 2023-10-11, under 510(k) number K232578.

Who is the listed applicant for VASSALLO GT 018 G12; VASSALLO GT 018 G30?

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

What is the FDA product code for VASSALLO GT 018 G12; VASSALLO GT 018 G30?

The FDA product code for VASSALLO GT 018 G12; VASSALLO GT 018 G30 is DQX.

Other records listing Filmec 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.

K232574VASSALLO GT Crossing14

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

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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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