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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K101015
Device Name GUIDE CATHETERS AND ACCESSORIES
Applicant
Thomas Medical Products, Inc.
65 Great Valley Pkwy.
Malvern,  PA  19355
Applicant Contact TIM STOUDT
Correspondent
Thomas Medical Products, Inc.
65 Great Valley Pkwy.
Malvern,  PA  19355
Correspondent Contact TIM STOUDT
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/12/2010
Decision Date 09/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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