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FDA 510(k)

SLIDEWIRETM(TRADEMARK PENDING)

K-Number: K113162 · 2012-07-20

ApplicantAcme-Monaco Corp.
Decision Date2012-07-20
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SLIDEWIRETM(TRADEMARK PENDING) 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 2012-07-20 under 510(k) number K113162. 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 SLIDEWIRETM(TRADEMARK PENDING)?

SLIDEWIRETM(TRADEMARK PENDING) is a medical device that received FDA 510(k) clearance on 2012-07-20. The listed applicant is Acme-Monaco Corp.. The 510(k) number is K113162.

When did SLIDEWIRETM(TRADEMARK PENDING) receive FDA 510(k) clearance?

SLIDEWIRETM(TRADEMARK PENDING) received FDA 510(k) clearance on 2012-07-20, under 510(k) number K113162.

Who is the listed applicant for SLIDEWIRETM(TRADEMARK PENDING)?

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 SLIDEWIRETM(TRADEMARK PENDING)?

The FDA product code for SLIDEWIRETM(TRADEMARK PENDING) is DQX.

Related Clinical Trials

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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.

K920884GUIDEWIRES, VARIOUS TYPESK895854ACME 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

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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