MitraClip™ SGC0801

GUDID 05415067050908

G5 Steerable Guide Catheter

ST. JUDE MEDICAL, INC.

Vascular guide-catheter, single-use

• Primary Device ID: 05415067050908
• NIH Device Record Key: c8c229c9-149c-44f8-92af-48baaa56b731
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MitraClip™
• Version Model Number: SGC0801
• Catalog Number: SGC0801
• Company DUNS: 149818952
• Company Name: ST. JUDE 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: false
• 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

Customer Support Contacts

• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Device Dimensions

• Outer Diameter: 8.4 Millimeter
• Outer Diameter: 8.4 Millimeter
• Outer Diameter: 8.4 Millimeter
• Outer Diameter: 8.4 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067050908 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243224

FDA Product Code

• DQY: Catheter, percutaneous

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: 2025-12-19
• Device Publish Date: 2025-12-11

On-Brand Devices [MitraClip™]

• 05415067037435: Clip Delivery System
• 05415067037404: Clip Delivery System
• 05415067037381: Clip Delivery System
• 05415067037367: Clip Delivery System
• 05415067050908: G5 Steerable Guide Catheter
• 05415067050779: G5 Delivery System
• 05415067050762: G5 Delivery System
• 05415067050748: G5 Delivery System
• 05415067050717: G5 Delivery System