CLEANER Vac™ 70027518

GUDID 00886333227167

CLEANER Vac™ Thrombectomy System - 18F OD x 115cm

ARGON MEDICAL DEVICES, INC.

Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter

• Primary Device ID: 00886333227167
• NIH Device Record Key: 4b4cf4c8-d170-4bce-8b16-0f923fae90f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEANER Vac™
• Version Model Number: 70027518
• Catalog Number: 70027518
• Company DUNS: 140727624
• Company Name: ARGON MEDICAL DEVICES, 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: true
• 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: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886333227167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232679

FDA Product Code

• QEW: Peripheral Mechanical Thrombectomy With Aspiration

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: 2024-04-25
• Device Publish Date: 2024-04-17

On-Brand Devices [CLEANER Vac™]

• 00886333227624: Cleaner Vac™ Aspiration Canister
• 00886333227174: Cleaner Vac™ - 18F OD x 115cm Aspiration Catheter with Handpiece
• 00886333227167: CLEANER Vac™ Thrombectomy System - 18F OD x 115cm