Cleared Traditional

Agilis HisPro Steerable Catheter With Electrodes

K200721 · Abbott (St. Jude Medical) · Cardiovascular
Jun 2020
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K200721 is an FDA 510(k) clearance for the Agilis HisPro Steerable Catheter With Electrodes, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Abbott (St. Jude Medical) (Sylamr, US). The FDA issued a Cleared decision on June 3, 2020, 76 days after receiving the submission on March 19, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K200721 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 2020
Decision Date June 03, 2020
Days to Decision 76 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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