QuickClear Aspiration Catheter, 6F x 130cm Straight AC6ST130

GUDID 00845225003081

VOLCANO ATHEROMED, INC.

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• Primary Device ID: 00845225003081
• NIH Device Record Key: f64a629b-38fc-4b5c-b8c8-90947be35890
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuickClear Aspiration Catheter, 6F x 130cm Straight
• Version Model Number: AC6ST130
• Catalog Number: AC6ST130
• 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: 130 Centimeter
• Length: 130 Centimeter
• Length: 130 Centimeter
• Length: 130 Centimeter
• Length: 130 Centimeter
• Length: 130 Centimeter
• Length: 130 Centimeter
• Length: 130 Centimeter
• Length: 130 Centimeter
• Length: 130 Centimeter
• Length: 130 Centimeter
• Length: 130 Centimeter
• Length: 130 Centimeter
• Length: 130 Centimeter
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845225003081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193197

FDA Product Code

• DXE: Catheter, Embolectomy
• QEZ: Aspiration Thrombectomy Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-10-26
• Device Publish Date: 2020-06-11

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• 00845225003081 - QuickClear Aspiration Catheter, 6F x 130cm Straight: 2021-10-26
• 00845225003081 - QuickClear Aspiration Catheter, 6F x 130cm Straight: 2021-10-26