VesPenetrator®

GUDID 06934184003035

Dongguan TT Medical, Inc.

Coronary angioplasty balloon catheter, basic

• Primary Device ID: 06934184003035
• NIH Device Record Key: 5cb74df5-eb93-4f2b-97fe-0bb775ee9264
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VesPenetrator®
• Version Model Number: PD15030
• Company DUNS: 551476865
• Company Name: Dongguan TT 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06934184003035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230374

FDA Product Code

• LOX: Catheters, Transluminal Coronary Angioplasty, 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: 2024-08-05
• Device Publish Date: 2024-07-26

On-Brand Devices [VesPenetrator®]

• 06934184003134: PD17538
• 06934184003127: PD17534
• 06934184003110: PD17530
• 06934184003103: PD17526
• 06934184003097: PD17522
• 06934184003080: PD17518
• 06934184003073: PD17514
• 06934184003066: PD17510
• 06934184003059: PD15038
• 06934184003042: PD15034
• 06934184003035: PD15030
• 06934184003028: PD15026
• 06934184003011: PD15022
• 06934184003004: PD15018
• 06934184002991: PD15014
• 06934184002984: PD15010