FDA 510(k)

REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406

K-Number: K024243 · 2003-06-20

Decision Date2003-06-20

Product CodeMCW

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406 is the device name listed in this FDA 510(k) record. The listed applicant is Fox Hollow Technologies. It received FDA 510(k) clearance on 2003-06-20 under 510(k) number K024243. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406?

REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406 is a medical device that received FDA 510(k) clearance on 2003-06-20. The listed applicant is Fox Hollow Technologies. The 510(k) number is K024243.

When did REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406 receive FDA 510(k) clearance?

REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406 received FDA 510(k) clearance on 2003-06-20, under 510(k) number K024243.

Who is the listed applicant for REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406?

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

What is the FDA product code for REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406?

The FDA product code for REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406 is MCW.

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Other records listing Fox Hollow Technologies as applicant

K071432SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE K071826THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910 K053460MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300,K043553SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300

Related Devices (Code: MCW)

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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.