Cleared Traditional

SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE

K070225 · Abiomed, Inc. · Cardiovascular
Dec 2007
Decision
323d
Days
Class 2
Risk

About This 510(k) Submission

K070225 is an FDA 510(k) clearance for the SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE, a System, Balloon, Intra-aortic And Control (Class II — Special Controls, product code DSP), submitted by Abiomed, Inc. (Danvers, US). The FDA issued a Cleared decision on December 13, 2007, 323 days after receiving the submission on January 24, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3535.

Submission Details

510(k) Number K070225 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 2007
Decision Date December 13, 2007
Days to Decision 323 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSP — System, Balloon, Intra-aortic And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3535

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