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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 K070212
Device Name CITOP10 GUIDEWIRE, 0.014(1.4MM TIP), CITOP6 GUIDEWIRE, 0.014(1.0MM TIP), CITOP SUPPORT ACCESSORY, 0.023(126CM)
Applicant
Ovalum , Ltd.
10, Plaut St. Rabin Park
Rehovot,  IL 76706
Applicant Contact KEN RAICHMAN
Correspondent
Ovalum , Ltd.
10, Plaut St. Rabin Park
Rehovot,  IL 76706
Correspondent Contact KEN RAICHMAN
Regulation Number870.1330
Classification Product Code
DQX  
Date Received01/22/2007
Decision Date 10/12/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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