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510(k) K231148

ScleroSafe™ 150 mm, ScleroSafe™ 350 mm by Vvt Medical , Ltd. — Product Code KRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2023
Date Received
April 21, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Continuous Flush
Device Class
Class II
Regulation Number
870.1210
Review Panel
CV
Submission Type

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