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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K875337
Device Name HEPARIN COATED LUMINAL PACING CATHETER
Applicant
Spectramed, Inc.
1900 Williams Dr.
Oxnard,  CA  93030
Applicant Contact ROBERT L LEAVITT
Correspondent
Spectramed, Inc.
1900 Williams Dr.
Oxnard,  CA  93030
Correspondent Contact ROBERT L LEAVITT
Regulation Number870.1200
Classification Product Code
DQO  
Date Received12/30/1987
Decision Date 05/25/1988
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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