Chocolate PTCA BAlloon Catheter

GUDID M874CH141402010RX1

TRIREME MEDICAL, LLC

Coronary angioplasty balloon catheter, basic

• Primary Device ID: M874CH141402010RX1
• NIH Device Record Key: b6f15d54-bc1a-4c01-b1f8-3e4dcd378d13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chocolate PTCA BAlloon Catheter
• 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: 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
HIBCC	M874CH141402010RX1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133633

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 PTCA BAlloon Catheter]

• M874CH141403520RX1: A
• M874CH141403515RX1: A
• M874CH141403510RX1: A
• M874CH141403020RX1: A
• M874CH141403015RX1: A
• M874CH141403010RX1: A
• M874CH141402520RX1: A
• M874CH141402515RX1: A
• M874CH141402510RX1: A
• M874CH141402020RX1: A
• M874CH141402015RX1: A
• M874CH141402010RX1: A