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FDA 510(k)

TORQUE DEVICE FOR A GUIDE WIRE

K-Number: K910969 · 1991-05-16

ApplicantTerumo Corp.
Decision Date1991-05-16
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TORQUE DEVICE FOR A GUIDE WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Corp.. It received FDA 510(k) clearance on 1991-05-16 under 510(k) number K910969. 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 TORQUE DEVICE FOR A GUIDE WIRE?

TORQUE DEVICE FOR A GUIDE WIRE is a medical device that received FDA 510(k) clearance on 1991-05-16. The listed applicant is Terumo Corp.. The 510(k) number is K910969.

When did TORQUE DEVICE FOR A GUIDE WIRE receive FDA 510(k) clearance?

TORQUE DEVICE FOR A GUIDE WIRE received FDA 510(k) clearance on 1991-05-16, under 510(k) number K910969.

Who is the listed applicant for TORQUE DEVICE FOR A GUIDE WIRE?

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

What is the FDA product code for TORQUE DEVICE FOR A GUIDE WIRE?

The FDA product code for TORQUE DEVICE FOR A GUIDE WIRE is DQX.

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Other records listing Terumo 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.

K100282TERUMO SURSHIELD- PUR SAFETY I.V. CATHETERK092372HEARTRAIL III GUIDING CATHETERK091417SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527AK090973TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)K073474CAPIOX CIRCUIT CONNECTORSK071572CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

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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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