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FDA 510(k)

HI-TORQUE PROGRESS GUIDE WIRE FAMILY

K-Number: K091825 · 2009-09-25

ApplicantAbbott Vascular, Inc.
Decision Date2009-09-25
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HI-TORQUE PROGRESS GUIDE WIRE FAMILY is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Vascular, Inc.. It received FDA 510(k) clearance on 2009-09-25 under 510(k) number K091825. 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 HI-TORQUE PROGRESS GUIDE WIRE FAMILY?

HI-TORQUE PROGRESS GUIDE WIRE FAMILY is a medical device that received FDA 510(k) clearance on 2009-09-25. The listed applicant is Abbott Vascular, Inc.. The 510(k) number is K091825.

When did HI-TORQUE PROGRESS GUIDE WIRE FAMILY receive FDA 510(k) clearance?

HI-TORQUE PROGRESS GUIDE WIRE FAMILY received FDA 510(k) clearance on 2009-09-25, under 510(k) number K091825.

Who is the listed applicant for HI-TORQUE PROGRESS GUIDE WIRE FAMILY?

The FDA 510(k) record lists Abbott Vascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HI-TORQUE PROGRESS GUIDE WIRE FAMILY?

The FDA product code for HI-TORQUE PROGRESS GUIDE WIRE FAMILY is DQX.

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Other records listing Abbott Vascular, Inc. 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.

K123067PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILYK122573HI-TORQUE COMMAND GUIDE WIRE FAMILYK102705ARMADA 14 PTA CATHETERK101648HI-TORQUE WINN GUIDE WIRE FAMILYK101011HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSALK081417FOXCROSS PTA CATHETER

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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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