Chocolate XD PTCA Balloon Catheter Hydrophilic Coated

GUDID M874CX141403520RX1

TRIREME MEDICAL, LLC

Coronary angioplasty balloon catheter, basic

• Primary Device ID: M874CX141403520RX1
• NIH Device Record Key: 26353517-db3d-4c0b-b247-cfba06a6762f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chocolate XD PTCA Balloon Catheter Hydrophilic Coated
• Version Model Number: A
• Company DUNS: 623861577
• Company Name: TRIREME MEDICAL, LLC
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M874CX141403520RX1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153682

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-07
• Device Publish Date: 2017-02-13

On-Brand Devices [Chocolate XD PTCA Balloon Catheter Hydrophilic Coated]

• M874CX141403520RX1: A
• M874CX141403515RX1: A
• M874CX141403510RX1: A
• M874CX141403020RX1: A
• M874CX141403015RX1: A
• M874CX141403010RX1: A
• M874CX141402520RX1: A
• M874CX141402515RX1: A
• M874CX141402510RX1: A
• M874CX141402020RX1: A
• M874CX141402015RX1: A
• M874CX141402010RX1: A