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FDA 510(k)

GUIDEWIRES, VARIOUS TYPES

K-Number: K920884 · 1992-08-19

ApplicantAcme-Monaco Corp.
Decision Date1992-08-19
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GUIDEWIRES, VARIOUS TYPES is the device name listed in this FDA 510(k) record. The listed applicant is Acme-Monaco Corp.. It received FDA 510(k) clearance on 1992-08-19 under 510(k) number K920884. 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 GUIDEWIRES, VARIOUS TYPES?

GUIDEWIRES, VARIOUS TYPES is a medical device that received FDA 510(k) clearance on 1992-08-19. The listed applicant is Acme-Monaco Corp.. The 510(k) number is K920884.

When did GUIDEWIRES, VARIOUS TYPES receive FDA 510(k) clearance?

GUIDEWIRES, VARIOUS TYPES received FDA 510(k) clearance on 1992-08-19, under 510(k) number K920884.

Who is the listed applicant for GUIDEWIRES, VARIOUS TYPES?

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

What is the FDA product code for GUIDEWIRES, VARIOUS TYPES?

The FDA product code for GUIDEWIRES, VARIOUS TYPES is DQX.

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Other records listing Acme-Monaco 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.

K113162SLIDEWIRETM(TRADEMARK PENDING)K895854ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE)K895483ACME COATED ORTHODONTIC ARCHWIREK883763ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH

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.

K253146Hyperdrive 35 GuidewireRapid-Medical , Ltd.K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.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.

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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