Excipio® LV PRIME Thrombectomy Device EXC-1607-150

GUDID 00851616007668

The Excipio® LV PRIME (Large Vessel) Thrombectomy Device (the “Device”) is a rapid exchange (RX) catheter with an integrated nitinol braided basket designed to mechanically displace thrombus.

Contego Medical, Inc.

Thrombectomy suction catheter

• Primary Device ID: 00851616007668
• NIH Device Record Key: 302f9216-6fce-4d86-9c6c-f38bf9f4dcbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Excipio® LV PRIME Thrombectomy Device
• Version Model Number: EXC-1607-150
• Catalog Number: EXC-1607-150
• Company DUNS: 048268128
• Company Name: Contego Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1-800-708-7271
• Email: info@contegomedical.com
• Phone: +1-800-708-7271
• Email: info@contegomedical.com
• Phone: +1-800-708-7271
• Email: info@contegomedical.com
• Phone: +1-800-708-7271
• Email: info@contegomedical.com
• Phone: +1-800-708-7271
• Email: info@contegomedical.com
• Phone: +1-800-708-7271
• Email: info@contegomedical.com
• Phone: +1-800-708-7271
• Email: info@contegomedical.com
• Phone: +1-800-708-7271
• Email: info@contegomedical.com
• Phone: +1-800-708-7271
• Email: info@contegomedical.com
• Phone: +1-800-708-7271
• Email: info@contegomedical.com
• Phone: +1-800-708-7271
• Email: info@contegomedical.com
• Phone: +1-800-708-7271
• Email: info@contegomedical.com
• Phone: +1-800-708-7271
• Email: info@contegomedical.com
• Phone: +1-800-708-7271
• Email: info@contegomedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851616007668 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251485

FDA Product Code

• QEW: Peripheral Mechanical Thrombectomy With Aspiration

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: 2025-08-04
• Device Publish Date: 2025-07-25

Devices Manufactured by Contego Medical, Inc.

• 00851616007668 - Excipio® LV PRIME Thrombectomy Device: 2025-08-04The Excipio® LV PRIME (Large Vessel) Thrombectomy Device (the “Device”) is a rapid exchange (RX) catheter with an integrated nitinol braided basket designed to mechanically displace thrombus.
• 00851616007668 - Excipio® LV PRIME Thrombectomy Device: 2025-08-04 The Excipio® LV PRIME (Large Vessel) Thrombectomy Device (the “Device”) is a rapid exchange (RX) catheter with an integrate
• 00851616007620 - Neuroguard IEP® System: 2025-01-29 The Neuroguard IEP System consists of three main components: • A self-expanding nitinol stent • A delivery catheter which in
• 00851616007637 - Neuroguard IEP® System: 2025-01-29 The Neuroguard IEP System consists of three main components: • A self-expanding nitinol stent • A delivery catheter which in
• 00851616007644 - Neuroguard IEP® System: 2025-01-29 The Neuroguard IEP System consists of three main components: • A self-expanding nitinol stent • A delivery catheter which in
• 00851616007651 - Neuroguard IEP® System: 2025-01-29 The Neuroguard IEP System consists of three main components: • A self-expanding nitinol stent • A delivery catheter which in
• 00851616007583 - Neuroguard IEP® System: 2024-10-31 The Neuroguard IEP System consists of three main components: • A self-expanding nitinol stent • A delivery catheter which in
• 00851616007590 - Neuroguard IEP® System: 2024-10-31 The Neuroguard IEP System consists of three main components: • A self-expanding nitinol stent • A delivery catheter which in
• 00851616007606 - Neuroguard IEP® System: 2024-10-31 The Neuroguard IEP System consists of three main components: • A self-expanding nitinol stent • A delivery catheter which in