PHOENIX ATHERECTOMY DEFLECTING SYSTEM, 2.4MM X 130CM, 7F

GUDID 00845225003197

VOLCANO ATHEROMED, INC.

Mechanical atherectomy system catheter, peripheral

• Primary Device ID: 00845225003197
• NIH Device Record Key: 177fd94f-5404-49a7-b618-b5815fa0680f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PHOENIX ATHERECTOMY DEFLECTING SYSTEM, 2.4MM X 130CM, 7F
• Version Model Number: PD24130K
• Company DUNS: 788341084
• Company Name: VOLCANO ATHEROMED, 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com

Device Dimensions

• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter
• Outer Diameter: 2.4 Millimeter
• Length: 130 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845225003197 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211518

FDA Product Code

• MCW: Catheter, Peripheral, Atherectomy

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: 2021-11-03
• Device Publish Date: 2021-10-26

Devices Manufactured by VOLCANO ATHEROMED, INC.

• 00845225003463 - Phoenix Atherectomy: 2024-07-16 Phoenix Atherectomy Catheter, 1.5mm x 149cm, 4F
• 00845225003470 - Phoenix Atherectomy: 2024-07-16 Phoenix Atherectomy Catheter, 1.8mm x 130cm, 5F
• 00845225003487 - Phoenix Atherectomy: 2024-07-16 Phoenix Atherectomy Catheter, 1.8mm x 149cm, 5F
• 00845225003494 - Phoenix Atherectomy: 2024-07-16 Phoenix Atherectomy Catheter, 2.2mm x 130cm, 6F
• 00845225003500 - Phoenix Atherectomy: 2024-07-16 Phoenix Atherectomy Catheter, 2.2mm x 149cm, 6F
• 00845225003517 - Phoenix Atherectomy: 2024-07-16 Phoenix Atherectomy Deflecting Catheter, 2.2mm x 130cm, 6F
• 00845225003524 - Phoenix Atherectomy: 2024-07-16 Phoenix Atherectomy Deflecting Catheter, 2.4mm x 130cm, 7F
• 00845225003531 - Phoenix Atherectomy: 2024-07-16 Phoenix Atherectomy System, 1.5mm x 149cm, 4F