Pounce™ Venous Thrombectomy System

GUDID 00812339030302

Pounce Venous Thrombectomy System

Surmodics, 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: 00812339030302
• NIH Device Record Key: 62f10dbf-e37c-47dc-8d9b-ba625715b76a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pounce™ Venous Thrombectomy System
• Version Model Number: VTS-1018-09010
• Company DUNS: 098414659
• Company Name: Surmodics, 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

Device Dimensions

• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0
• Catheter Length: 90 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812339030302 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201705

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: 2022-06-30
• Device Publish Date: 2022-06-22

On-Brand Devices [Pounce™ Venous Thrombectomy System]

• 00812339030302: Pounce Venous Thrombectomy System
• 00812339030791: Pounce Venous Thrombectomy System