Cleared Special

IMPELLA 2.5 PLUS CATHETER

K112892 · Abiomed, Inc. · Cardiovascular

Sep 2012

Decision

342d

Days

—

Risk

About This 510(k) Submission

K112892 is an FDA 510(k) clearance for the IMPELLA 2.5 PLUS CATHETER, submitted by Abiomed, Inc. (Danvers, US). The FDA issued a Cleared decision on September 6, 2012, 342 days after receiving the submission on September 30, 2011. This device falls under the Cardiovascular review panel.

Submission Details

510(k) Number	K112892 FDA.gov
FDA Decision	Cleared SESU
Date Received	September 30, 2011
Decision Date	September 06, 2012
Days to Decision	342 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF