Cleared Special

ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR090-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR110-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR135-18N),

K202252 · Asahi Intecc Co., Ltd. · Cardiovascular

Sep 2020

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K202252 is an FDA 510(k) clearance for the ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR090-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR110-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR135-18N),, 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 September 8, 2020, 29 days after receiving the submission on August 10, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K202252 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 10, 2020
Decision Date	September 08, 2020
Days to Decision	29 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF