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FDA 510(k)

MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER

K-Number: K110617 · 2011-06-02

ApplicantAbbott Vascular
Decision Date2011-06-02
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Vascular. It received FDA 510(k) clearance on 2011-06-02 under 510(k) number K110617. 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 RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER?

MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2011-06-02. The listed applicant is Abbott Vascular. The 510(k) number is K110617.

When did MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER receive FDA 510(k) clearance?

MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER received FDA 510(k) clearance on 2011-06-02, under 510(k) number K110617.

Who is the listed applicant for MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER?

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

What is the FDA product code for MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER?

The FDA product code for MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER is LOX.

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Related Devices (Code: LOX)

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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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