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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K882804
Device Name 0.014 PERIPHERAL GUIDE WIRE
Applicant
Intensive Technology, Inc.
3574 Ruffin Rd.
San Diego,  CA  92123
Applicant Contact MICHAEL KLICPERA
Correspondent
Intensive Technology, Inc.
3574 Ruffin Rd.
San Diego,  CA  92123
Correspondent Contact MICHAEL KLICPERA
Regulation Number870.1330
Classification Product Code
DQX  
Date Received07/07/1988
Decision Date 10/28/1988
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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