PathBuilder Steerable Introducer

GUDID 06952450970065

Shanghai Microport Ep Medtech Co., Ltd.

Cardiac transseptal access set

• Primary Device ID: 06952450970065
• NIH Device Record Key: e1d27ffc-113f-4993-aa70-d9434df842c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PathBuilder Steerable Introducer
• Version Model Number: C.GK.S61
• Company DUNS: 542965535
• Company Name: Shanghai Microport Ep Medtech Co., Ltd.
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06952450970065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211530

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: 2024-03-04
• Device Publish Date: 2024-02-23

On-Brand Devices [PathBuilder Steerable Introducer]

• 06952450973318: C.GK.X71
• 06952450970072: C.GK.M61
• 06952450970065: C.GK.S61
• 06952450970058: C.GK.L71
• 06952450970041: C.GK.M71
• 06952450970034: C.GK.S71