Excipio SV EXC-0940-165

GUDID 00851616007491

The Excipio SV Thrombectomy Device is indicated for the non-surgical removal of soft emboli and thrombi from peripheral blood vessels.

Contego Medical, Inc.

Thrombectomy suction catheter

• Primary Device ID: 00851616007491
• NIH Device Record Key: 6b02939b-adfe-4ebd-baf8-dd2f56fb2d7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Excipio SV
• Version Model Number: EXC-0940-165
• Catalog Number: EXC-0940-165
• 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: +1-919-459-7250
• Email: info@contegomedical.com
• Phone: +1-919-459-7250
• Email: info@contegomedical.com
• Phone: +1-919-459-7250
• Email: info@contegomedical.com
• Phone: +1-919-459-7250
• Email: info@contegomedical.com
• Phone: +1-919-459-7250
• Email: info@contegomedical.com
• Phone: +1-919-459-7250
• Email: info@contegomedical.com
• Phone: +1-919-459-7250
• Email: info@contegomedical.com
• Phone: +1-919-459-7250
• Email: info@contegomedical.com
• Phone: +1-919-459-7250
• Email: info@contegomedical.com
• Phone: +1-919-459-7250
• Email: info@contegomedical.com
• Phone: +1-919-459-7250
• Email: info@contegomedical.com
• Phone: +1-919-459-7250
• Email: info@contegomedical.com
• Phone: +1-919-459-7250
• Email: info@contegomedical.com
• Phone: +1-919-459-7250
• Email: info@contegomedical.com
• Phone: +1-919-459-7250
• Email: info@contegomedical.com
• Phone: +1-919-459-7250
• Email: info@contegomedical.com
• Phone: +1-919-459-7250
• Email: info@contegomedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851616007491 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221204

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: 2023-09-13
• Device Publish Date: 2023-09-05

Devices Manufactured by Contego Medical, Inc.

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• 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