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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, Short-Term Less Than 30 Days
510(k) Number K983409
Device Name V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) SEE APPENDIX 1
Applicant
Hdc Corp.
2109 O'Toole Ave.
San Jose,  CA  95131
Applicant Contact JAMES S ABILLA
Correspondent
Hdc Corp.
2109 O'Toole Ave.
San Jose,  CA  95131
Correspondent Contact JAMES S ABILLA
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received09/28/1998
Decision Date 10/16/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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