Cleared Special

K112892 - IMPELLA 2.5 PLUS CATHETER (FDA 510(k) Clearance)

K112892 · Abiomed, Inc. · Cardiovascular device
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Sep 2012
Decision
342d
Days
-
Risk

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 after a review of 342 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Elevated predicate reliance profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Abiomed, Inc. devices

Submission Details

510(k) Number K112892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
217d slower than avg
Panel avg: 125d · This submission: 342d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PBL
Device Class -