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FDA 510(k)

IMPELLA CONTROLLER WITH FLOW CONTROL

K-Number: K110845 · 2011-04-27

ApplicantAbiomed, Inc.
Decision Date2011-04-27
Product CodeKFM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IMPELLA CONTROLLER WITH FLOW CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Abiomed, Inc.. It received FDA 510(k) clearance on 2011-04-27 under 510(k) number K110845. The device is classified under product code KFM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPELLA CONTROLLER WITH FLOW CONTROL?

IMPELLA CONTROLLER WITH FLOW CONTROL is a medical device that received FDA 510(k) clearance on 2011-04-27. The listed applicant is Abiomed, Inc.. The 510(k) number is K110845.

When did IMPELLA CONTROLLER WITH FLOW CONTROL receive FDA 510(k) clearance?

IMPELLA CONTROLLER WITH FLOW CONTROL received FDA 510(k) clearance on 2011-04-27, under 510(k) number K110845.

Who is the listed applicant for IMPELLA CONTROLLER WITH FLOW CONTROL?

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 CONTROLLER WITH FLOW CONTROL?

The FDA product code for IMPELLA CONTROLLER WITH FLOW CONTROL is KFM.

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Related Devices (Code: KFM)

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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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