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FDA 510(k)

MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER

K-Number: K103110 · 2011-01-10

ApplicantAbbott Vascular-Cardiac Therapies
Decision Date2011-01-10
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER 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 2011-01-10 under 510(k) number K103110. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER?

MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2011-01-10. The listed applicant is Abbott Vascular-Cardiac Therapies. The 510(k) number is K103110.

When did MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER receive FDA 510(k) clearance?

MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER received FDA 510(k) clearance on 2011-01-10, under 510(k) number K103110.

Who is the listed applicant for MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER?

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 MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER?

The FDA product code for MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER is LOX.

Related Clinical Trials

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.

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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 CATHETERK103101HI-TORQUE BALANCE MIDDLEWEIGHT ELITEK103153VOYAGER 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: LOX)

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.

K261428NC Euphora Rapid Exchange Balloon Dilatation CatheterMedtronic IrelandK261759Euphora Rapid Exchange (RX) Balloon Dilatation CatheterMedtronic IrelandK252116Firefighter™ Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd.K254022FLASH Flex™ Aorto-Ostial Angioplasty SystemVerge Medical, Inc.K252295RyureiTerumo CorporationK251970Sprinter Legend Rapid Exchange Balloon Dilatation CatheterMedtronic, Ireland

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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