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FDA 510(k)

IMPELLA 2.5 PLUS CATHETER

K-Number: K112892 · 2012-09-06

ApplicantAbiomed, Inc.
Decision Date2012-09-06
Product CodePBL
Advisory CommitteeCV
DecisionUnknown

Device Summary

IMPELLA 2.5 PLUS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Abiomed, Inc.. It received FDA 510(k) clearance on 2012-09-06 under 510(k) number K112892. The device is classified under product code PBL. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the IMPELLA 2.5 PLUS CATHETER?

IMPELLA 2.5 PLUS CATHETER is a medical device that received FDA 510(k) clearance on 2012-09-06. The listed applicant is Abiomed, Inc.. The 510(k) number is K112892.

When did IMPELLA 2.5 PLUS CATHETER receive FDA 510(k) clearance?

IMPELLA 2.5 PLUS CATHETER received FDA 510(k) clearance on 2012-09-06, under 510(k) number K112892.

Who is the listed applicant for IMPELLA 2.5 PLUS CATHETER?

The FDA 510(k) record lists Abiomed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMPELLA 2.5 PLUS CATHETER?

The FDA product code for IMPELLA 2.5 PLUS CATHETER is PBL.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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