LMI OCCLUSION CATHETER

GUDID B3805FOCC400

LUCAS MEDICAL INC

Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided

• Primary Device ID: B3805FOCC400
• NIH Device Record Key: 79b3f660-39a5-4121-97ea-f3d4d5dd065e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LMI OCCLUSION CATHETER
• Version Model Number: 5FOCC40
• 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	B3805FOCC400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955125

FDA Product Code

• DXE: Catheter, Embolectomy

Sterilization

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

[B3805FOCC400]

Ethylene Oxide

[B3805FOCC400]

Ethylene Oxide

[B3805FOCC400]

Ethylene Oxide

[B3805FOCC400]

Ethylene Oxide

[B3805FOCC400]

Ethylene Oxide

[B3805FOCC400]

Ethylene Oxide

[B3805FOCC400]

Ethylene Oxide

[B3805FOCC400]

Ethylene Oxide

[B3805FOCC400]

Ethylene Oxide

[B3805FOCC400]

Ethylene Oxide

[B3805FOCC400]

Ethylene Oxide

[B3805FOCC400]

Ethylene Oxide

[B3805FOCC400]

Ethylene Oxide

[B3805FOCC400]

Ethylene Oxide

[B3805FOCC400]

Ethylene Oxide

[B3805FOCC400]

Ethylene Oxide

[B3805FOCC400]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-21
• Device Publish Date: 2016-09-02

On-Brand Devices [LMI OCCLUSION CATHETER]

• B3808FOCC400: 8FOCC40
• B3808FOCC230: 8FOCC23
• B3807FOCC400: 7FOCC40
• B3807FOCC230: 7FOCC23
• B3806FOCC400: 6FOCC40
• B3806FOCC230: 6FOCC23
• B3805FOCC400: 5FOCC40
• B3805FOCC230: 5FOCC23
• B3804FOCC400: 4FOCC40
• B3804FOCC230: 4FOCC23
• B3803FOCC400: 3FOCC40
• B3803FOCC230: 3FOCC23