Cleared Traditional

WATCHMAN TruSeal Access System

K180864 · Boston Scientific · Cardiovascular
Jul 2018
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K180864 is an FDA 510(k) clearance for the WATCHMAN TruSeal Access System, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Boston Scientific (Maple Gove, US). The FDA issued a Cleared decision on July 20, 2018, 109 days after receiving the submission on April 2, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K180864 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 2018
Decision Date July 20, 2018
Days to Decision 109 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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