Impella CP Introducer
K-Number: K192769 · 2019-11-18
ApplicantAbiomed, Inc.
Decision Date2019-11-18
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Impella CP Introducer is a medical device manufactured by Abiomed, Inc.. It received FDA 510(k) clearance on 2019-11-18 under approval number K192769. 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 CP Introducer?
Impella CP Introducer is a medical device that received FDA 510(k) clearance on 2019-11-18. It is manufactured by Abiomed, Inc.. The 510(k) number is K192769.
When was Impella CP Introducer approved by the FDA?
Impella CP Introducer received FDA 510(k) clearance on 2019-11-18, under approval number K192769.
What company makes Impella CP Introducer?
Impella CP Introducer is manufactured by Abiomed, Inc..
What is the FDA product code for Impella CP Introducer?
The FDA product code for Impella CP Introducer is DYB.
Other Devices by Abiomed, Inc.
Related Devices (Code: DYB)
K162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. ModelAccess Scientific, LLC
K162097InTRAkitMedtronic Vascular
K162769Pinpoint GT Introducer NeedleC.R. Bard, Inc.
K153771TXM Guiding SheathTexasmedical Technologies, Inc.
K162184Edwards eSheath Introducer SetEdward Lifesciences
K153494HQS Introducer (Model 2064-HQS)Alseal
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.