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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stripper, Vein, External
510(k) Number K885046
Device Name INSITUCAT VALVE STRIPPER
Applicant
Aesculap Instruments Corp.
875 Stanton Rd.
Burlingame,  CA  94010
Applicant Contact ROBIN BUSH
Correspondent
Aesculap Instruments Corp.
875 Stanton Rd.
Burlingame,  CA  94010
Correspondent Contact ROBIN BUSH
Regulation Number870.4885
Classification Product Code
DWQ  
Date Received12/05/1988
Decision Date 02/28/1990
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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