Cleared Traditional

ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3

K241158 · Asahi Intecc Co., Ltd. · Cardiovascular
Jun 2024
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K241158 is an FDA 510(k) clearance for the ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Asahi Intecc Co., Ltd. (Seto-Shi, JP). The FDA issued a Cleared decision on June 25, 2024, 60 days after receiving the submission on April 26, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K241158 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 2024
Decision Date June 25, 2024
Days to Decision 60 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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