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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K182937
Device Name Upstream GoBack Crossing Catheter
Applicant
Upstream Peripheral Technologies, Ltd.
Aran Bldg., P.O. Box 3067; 43 Ha'Eshel St.
Caesarea,  IL 3088900
Applicant Contact Dan Rottenberg
Correspondent
Hogan Lovells US LLP
1735 Market St.
23rd Floor
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number870.1250
Classification Product Code
DQY  
Date Received10/22/2018
Decision Date 05/23/2019
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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