Cleared Traditional

ScleroSafe? 150 mm, ScleroSafe? 350 mm

K231148 · Vvt Medical , Ltd. · Cardiovascular
Jun 2023
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K231148 is an FDA 510(k) clearance for the ScleroSafe? 150 mm, ScleroSafe? 350 mm, a Catheter, Continuous Flush (Class II — Special Controls, product code KRA), submitted by Vvt Medical , Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on June 20, 2023, 60 days after receiving the submission on April 21, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1210.

Submission Details

510(k) Number K231148 FDA.gov
FDA Decision Cleared SESE
Date Received April 21, 2023
Decision Date June 20, 2023
Days to Decision 60 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code KRA — Catheter, Continuous Flush
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1210

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