CVX-300 CVX-300-P

GUDID 00813132029937

Excimer Laser System

Spectranetics Corporation

Atherectomy excimer laser system Atherectomy excimer laser system Atherectomy excimer laser system Atherectomy excimer laser system Atherectomy excimer laser system Atherectomy excimer laser system Atherectomy excimer laser system Atherectomy excimer laser system Atherectomy excimer laser system Atherectomy excimer laser system Atherectomy excimer laser system Atherectomy excimer laser system Atherectomy excimer laser system Atherectomy excimer laser system Atherectomy excimer laser system Atherectomy excimer laser system Atherectomy excimer laser system Atherectomy excimer laser system Atherectomy excimer laser system Atherectomy excimer laser system Atherectomy excimer laser system Atherectomy excimer laser system Atherectomy excimer laser system Atherectomy excimer laser system Atherectomy excimer laser system Atherectomy excimer laser system Atherectomy excimer laser system Atherectomy excimer laser system Atherectomy excimer laser system Atherectomy excimer laser system Atherectomy excimer laser system Atherectomy excimer laser system 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

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