LMI THROMBECTOMY CATHETER

GUDID B3806FTHB800

LUCAS MEDICAL INC

Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter

• Primary Device ID: B3806FTHB800
• NIH Device Record Key: 8ad406a6-4915-41de-b89a-81d464d7f93d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LMI THROMBECTOMY CATHETER
• Version Model Number: 6FTHB80
• Company DUNS: 878198993
• Company Name: LUCAS 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B3806FTHB800 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970657

FDA Product Code

• DXE: Catheter, Embolectomy

Sterilization

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

[B3806FTHB800]

Ethylene Oxide

[B3806FTHB800]

Ethylene Oxide

[B3806FTHB800]

Ethylene Oxide

[B3806FTHB800]

Ethylene Oxide

[B3806FTHB800]

Ethylene Oxide

[B3806FTHB800]

Ethylene Oxide

[B3806FTHB800]

Ethylene Oxide

[B3806FTHB800]

Ethylene Oxide

[B3806FTHB800]

Ethylene Oxide

[B3806FTHB800]

Ethylene Oxide

[B3806FTHB800]

Ethylene Oxide

[B3806FTHB800]

Ethylene Oxide

[B3806FTHB800]

Ethylene Oxide

[B3806FTHB800]

Ethylene Oxide

[B3806FTHB800]

Ethylene Oxide

[B3806FTHB800]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-02

On-Brand Devices [LMI THROMBECTOMY CATHETER]

• B3808FTHB800: 8FTHB80
• B3808FTHB400: 8FTHB40
• B3807FTHB800: 7FTHB80
• B3807FTHB400: 7FTHB40
• B3806FTHB800: 6FTHB80
• B3806FTHB400: 6FTHB40
• B3805FTHB800: 5FTHB80
• B3805FTHB400: 5FTHB40
• B3804FTHB800: 4FTHB80
• B3804FTHB400: 4FTHB40
• B3803FTHB800: 3FTHB80
• B3803FTHB400: 3FTHB40