QuickClear Aspiration Catheter, 8F x 85cm Straight AC8ST085

GUDID 00845225003104

VOLCANO ATHEROMED, INC.

Thrombectomy suction catheter

• Primary Device ID: 00845225003104
• NIH Device Record Key: 965b74ad-73b3-4fbf-93e7-9938cb2927df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuickClear Aspiration Catheter, 8F x 85cm Straight
• Version Model Number: AC8ST085
• Catalog Number: AC8ST085
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 Centimeter
• Length: 85 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845225003104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193197

FDA Product Code

• QEZ: Aspiration Thrombectomy Catheter

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: 2022-01-27
• Device Publish Date: 2022-01-19

Devices Manufactured by VOLCANO ATHEROMED, INC.

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• 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