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FDA 510(k)

UMI STEERABLE TORQUE GUIDE WIRE

K-Number: K863178 · 1986-09-19

ApplicantUniversal Medical Instrument Corp.
Decision Date1986-09-19
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UMI STEERABLE TORQUE GUIDE WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Universal Medical Instrument Corp.. It received FDA 510(k) clearance on 1986-09-19 under 510(k) number K863178. 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 UMI STEERABLE TORQUE GUIDE WIRE?

UMI STEERABLE TORQUE GUIDE WIRE is a medical device that received FDA 510(k) clearance on 1986-09-19. The listed applicant is Universal Medical Instrument Corp.. The 510(k) number is K863178.

When did UMI STEERABLE TORQUE GUIDE WIRE receive FDA 510(k) clearance?

UMI STEERABLE TORQUE GUIDE WIRE received FDA 510(k) clearance on 1986-09-19, under 510(k) number K863178.

Who is the listed applicant for UMI STEERABLE TORQUE GUIDE WIRE?

The FDA 510(k) record lists Universal Medical Instrument Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UMI STEERABLE TORQUE GUIDE WIRE?

The FDA product code for UMI STEERABLE TORQUE GUIDE WIRE is DQX.

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Other records listing Universal Medical Instrument 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.

K962180CATH SEALK935077CATH-SEALK897128UMI BRAIDED CATHETER CONNECTORK881796UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLEK861984UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTROK860168UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE

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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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