Cleared Traditional

Target Detachable Coils

K153658 · Stryker Neurovascular · Neurology
May 2016
Decision
150d
Days
Class 2
Risk

About This 510(k) Submission

K153658 is an FDA 510(k) clearance for the Target Detachable Coils, a Device, Neurovascular Embolization (Class II — Special Controls, product code HCG), submitted by Stryker Neurovascular (Fremont, US). The FDA issued a Cleared decision on May 19, 2016, 150 days after receiving the submission on December 21, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5950.

Submission Details

510(k) Number K153658 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2015
Decision Date May 19, 2016
Days to Decision 150 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HCG — Device, Neurovascular Embolization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5950

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