Cleared Traditional

SUPRACOR BALLOON CATHETER

K062582 · Abiomed, Inc. · Cardiovascular
Dec 2006
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K062582 is an FDA 510(k) clearance for the SUPRACOR BALLOON CATHETER, 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 14, 2006, 105 days after receiving the submission on August 31, 2006. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3535.

Submission Details

510(k) Number K062582 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 2006
Decision Date December 14, 2006
Days to Decision 105 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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