CVX-300 CVX-300-P

GUDID 00813132029937

Excimer Laser System

Spectranetics Corporation

Atherectomy excimer laser system

• Primary Device ID: 00813132029937
• NIH Device Record Key: 405755ee-70e8-4ce7-8c25-828445d8e613
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CVX-300
• Version Model Number: CVX-300-P
• Catalog Number: CVX-300-P
• Company DUNS: 151047370
• Company Name: Spectranetics Corporation
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813132029937 [Primary]
HIBCC	M204CVX300PAA0 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P910001

FDA Product Code

• LPC: Device, Angioplasty, Laser, Coronary

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-20
• Device Publish Date: 2022-10-12

Devices Manufactured by Spectranetics Corporation

• 00813132029944 - Turbo-Power: 2023-12-20 Turbo-Power Laser Atherectomy Catheter, 2.0mm
• 00813132029951 - Turbo-Power: 2023-12-20 Turbo-Power Laser Atherectomy Catheter, 2.3mm
• 00813132029937 - CVX-300: 2022-10-20Excimer Laser System
• 00813132029937 - CVX-300: 2022-10-20 Excimer Laser System
• M2041100010 - ELCA™: 2021-10-26 ELCA™ Coronary Laser Atherectomy Catheter
• M2041100020 - ELCA™: 2021-10-26 ELCA™ Coronary Laser Atherectomy Catheter
• M2041100030 - ELCA™: 2021-10-26 ELCA™ Coronary Laser Atherectomy Catheter
• M2041100040 - ELCA™: 2021-10-26 ELCA™ Coronary Laser Atherectomy Catheter
• M2041140090 - ELCA™: 2021-10-26 ELCA™ Coronary Laser Atherectomy Catheter