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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 K932619
Device Name TRANSSEPTAL INTRODUCER SET
Applicant
Thomas Medical Products, Inc.
65 Great Valley Pkwy.
Malvern,  PA  19355
Applicant Contact DAVID G CATLIN
Correspondent
Thomas Medical Products, Inc.
65 Great Valley Pkwy.
Malvern,  PA  19355
Correspondent Contact DAVID G CATLIN
Regulation Number870.1250
Classification Product Code
DQY  
Date Received06/01/1993
Decision Date 08/24/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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