Cleared Special

Branchor Balloon Guide Catheter

K221951 · Asahi Intecc Co., Ltd. · Neurology

Oct 2022

Decision

98d

Days

Class 2

Risk

About This 510(k) Submission

K221951 is an FDA 510(k) clearance for the Branchor Balloon Guide Catheter, a Catheter, Percutaneous, Neurovasculature (Class II — Special Controls, product code QJP), submitted by Asahi Intecc Co., Ltd. (Seto-Shi, JP). The FDA issued a Cleared decision on October 11, 2022, 98 days after receiving the submission on July 5, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K221951 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 05, 2022
Decision Date	October 11, 2022
Days to Decision	98 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	QJP — Catheter, Percutaneous, Neurovasculature
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1250
Definition	To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures