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FDA 510(k)

IMPELLA 5.0 CATHETER FAMILY

K-Number: K083111 · 2009-04-16

ApplicantAbiomed, Inc.
Decision Date2009-04-16
Product CodeKFM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IMPELLA 5.0 CATHETER FAMILY is the device name listed in this FDA 510(k) record. The listed applicant is Abiomed, Inc.. It received FDA 510(k) clearance on 2009-04-16 under 510(k) number K083111. 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 5.0 CATHETER FAMILY?

IMPELLA 5.0 CATHETER FAMILY is a medical device that received FDA 510(k) clearance on 2009-04-16. The listed applicant is Abiomed, Inc.. The 510(k) number is K083111.

When did IMPELLA 5.0 CATHETER FAMILY receive FDA 510(k) clearance?

IMPELLA 5.0 CATHETER FAMILY received FDA 510(k) clearance on 2009-04-16, under 510(k) number K083111.

Who is the listed applicant for IMPELLA 5.0 CATHETER FAMILY?

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 5.0 CATHETER FAMILY?

The FDA product code for IMPELLA 5.0 CATHETER FAMILY is 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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