Impella XR Sheath Set
K-Number: K202330 · 2020-12-07
ApplicantAbiomed, Inc.
Decision Date2020-12-07
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Impella XR Sheath Set is a medical device manufactured by Abiomed, Inc.. It received FDA 510(k) clearance on 2020-12-07 under approval number K202330. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Impella XR Sheath Set?
Impella XR Sheath Set is a medical device that received FDA 510(k) clearance on 2020-12-07. It is manufactured by Abiomed, Inc.. The 510(k) number is K202330.
When was Impella XR Sheath Set approved by the FDA?
Impella XR Sheath Set received FDA 510(k) clearance on 2020-12-07, under approval number K202330.
What company makes Impella XR Sheath Set?
Impella XR Sheath Set is manufactured by Abiomed, Inc..
What is the FDA product code for Impella XR Sheath Set?
The FDA product code for Impella XR Sheath Set is DYB.
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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.