Cleared Traditional

SUGITA TITANIUM ANEURYSM CLIP

K990202 · Mizuho America, Inc. · Neurology
Jun 1999
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K990202 is an FDA 510(k) clearance for the SUGITA TITANIUM ANEURYSM CLIP, a Clip, Aneurysm (Class II — Special Controls, product code HCH), submitted by Mizuho America, Inc. (Rockville, US). The FDA issued a Cleared decision on June 4, 1999, 134 days after receiving the submission on January 21, 1999. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5200.

Submission Details

510(k) Number K990202 FDA.gov
FDA Decision Cleared SESE
Date Received January 21, 1999
Decision Date June 04, 1999
Days to Decision 134 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HCH — Clip, Aneurysm
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5200

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