ThromTom - ThromTom 510K Presentation Medical Device Erica...

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Click to edit Master subtitle style 7/8/11 ThromTom 510K Presentation Medical Device Erica Shwarz Dhairya Pujara Yogesh Prasad Balajee
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Click to edit Master subtitle style 7/8/11 WHAT IS IT? SINGLE USE, DISPOSABLE SYSTEM DESIGNED FOR REMOVING THROMBUS FROM CORONARY ARTERIES
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7/8/11 COMPONENTS CATHETER HAS 6F SHEATH CONTSTRUCTED WITH NYLON BLEND 150 CM IN LENGTH DESIGNED WITH A DISTAL TIP THAT INCASES THE HELIX TO MACERATE THROMBUS CONTROL UNIT MOTOR THAT POWERS EXTRACTION HELICAL PUMP CONNECTS TO THE POWER SUPPLY
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7/8/11 STANDARDS APPROVED FOR CE MARK FOR EU CONFORMS TO GLP GMP ISO OSHA
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PREDICATE DEVICES Manufacturer Device Difference Date approved Microvena Corporation Amplatz Infusion Line attached for passage of saline November 1988 Kensey Nash Corporation ThromCat 7 F sheath length April 2005 EV3 Inc X-Sizer catheter Catheter diameter, motor RPM September 2004
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DEVICE CLASSIFICATION Proposed device classification: CLASS II, 21 CFR 870.4875, MCW TITLE 21 - FOOD AND DRUGS CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H - MEDICAL DEVICES
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PART 870 - CARDIOVASCULAR DEVICES subpart E - CARDIOVASCULAR SURGICAL DEVICES 870.4875 - Intraluminal artery stripper. (a) Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.) (b) Classification. Class II (performance standards). DEVICE CLASSIFICATION
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7/8/11 Clinical Trials FD A
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7/8/11 Clinical Trials Phase I will include approximately 60 patients with thrombus present in their coronary arteries.
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ThromTom - ThromTom 510K Presentation Medical Device Erica...

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