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FDA 510(k)

HI-TORQUE BALANCE MIDDLEWEIGHT ELITE

K-Number: K103101 · 2011-02-10

ApplicantAbbott Vascular-Cardiac Therapies
Decision Date2011-02-10
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HI-TORQUE BALANCE MIDDLEWEIGHT ELITE is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Vascular-Cardiac Therapies. It received FDA 510(k) clearance on 2011-02-10 under 510(k) number K103101. 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 BALANCE MIDDLEWEIGHT ELITE?

HI-TORQUE BALANCE MIDDLEWEIGHT ELITE is a medical device that received FDA 510(k) clearance on 2011-02-10. The listed applicant is Abbott Vascular-Cardiac Therapies. The 510(k) number is K103101.

When did HI-TORQUE BALANCE MIDDLEWEIGHT ELITE receive FDA 510(k) clearance?

HI-TORQUE BALANCE MIDDLEWEIGHT ELITE received FDA 510(k) clearance on 2011-02-10, under 510(k) number K103101.

Who is the listed applicant for HI-TORQUE BALANCE MIDDLEWEIGHT ELITE?

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

What is the FDA product code for HI-TORQUE BALANCE MIDDLEWEIGHT ELITE?

The FDA product code for HI-TORQUE BALANCE MIDDLEWEIGHT ELITE is DQX.

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Other records listing Abbott Vascular-Cardiac Therapies 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.

K112957HI-TORQUE POWERTURNK110134NC TREK RX CORONARY DILATATION CATHETERK103110MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETERK103153VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETERK101116HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH

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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