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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)
510(k) Number K941058
Device Name PROCATH PACING THRESHOLD CABLE
Applicant
Professional Catheter Corp.
334 D-6 Cooper Rd.
Berlin,  NJ  08009
Applicant Contact JOSEPH C GRIFFIN, III
Correspondent
Professional Catheter Corp.
334 D-6 Cooper Rd.
Berlin,  NJ  08009
Correspondent Contact JOSEPH C GRIFFIN, III
Regulation Number870.2900
Classification Product Code
DSA  
Date Received03/08/1994
Decision Date 07/11/1994
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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