Abiomed Impella CP 14Fr Introducer Kit

GUDID 00813502011685

Abiomed Impella CP 14Fr Introducer Kit, short (13cm)

Abiomed, Inc.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 00813502011685
• NIH Device Record Key: 40f56baa-bc34-48cd-9ec9-b47c40d09aa7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Abiomed Impella CP 14Fr Introducer Kit
• Version Model Number: 0052-3052
• Company DUNS: 050636737
• Company Name: Abiomed, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813502011685 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192769

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-19
• Device Publish Date: 2026-03-11

On-Brand Devices [Abiomed Impella CP 14Fr Introducer Kit]

• 00813502011692: Abiomed Impella CP 14Fr Introducer Kit, Long (25cm)
• 00813502011685: Abiomed Impella CP 14Fr Introducer Kit, short (13cm)