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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, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K883313
Device Name PMT VASCULAR CATHETER MODEL NUMBER 3621-1
Applicant
Pmt Corp.
1500 Park Rd.
Chanhassen,  MN  55317
Applicant Contact AL IVERSEN
Correspondent
Pmt Corp.
1500 Park Rd.
Chanhassen,  MN  55317
Correspondent Contact AL IVERSEN
Regulation Number880.5970
Classification Product Code
LJS  
Date Received08/05/1988
Decision Date 10/04/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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