Cleared Special

AC3 Series Intra-Aortic Balloon Pump (IABP)

K192238 · Arrow International, Teleflex · Cardiovascular

Nov 2019

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K192238 is an FDA 510(k) clearance for the AC3 Series Intra-Aortic Balloon Pump (IABP), a System, Balloon, Intra-aortic And Control (Class II — Special Controls, product code DSP), submitted by Arrow International, Teleflex (Chelmsford, US). The FDA issued a Cleared decision on November 12, 2019, 85 days after receiving the submission on August 19, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3535.

Submission Details

510(k) Number	K192238 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 19, 2019
Decision Date	November 12, 2019
Days to Decision	85 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF