JETi Peripheral Catheter WV8100

GUDID B139WV81000

WALK VASCULAR L.L.C.

Thrombectomy suction catheter

• Primary Device ID: B139WV81000
• NIH Device Record Key: f8cb0569-417d-483d-b614-ae794f281b8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JETi Peripheral Catheter
• Version Model Number: WV8100
• Catalog Number: WV8100
• Company DUNS: 034774488
• Company Name: WALK VASCULAR L.L.C.
• 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

• Length: 100 Centimeter
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Catheter Gauge: 8 French

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B139WV81000 [Primary]
HIBCC	B139WV81001 [Package]; Package: Carton Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163051

FDA Product Code

• DXE: Catheter, Embolectomy

Sterilization

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

[B139WV81000]

Ethylene Oxide

[B139WV81000]

Ethylene Oxide

[B139WV81000]

Ethylene Oxide

[B139WV81000]

Ethylene Oxide

[B139WV81000]

Ethylene Oxide

[B139WV81000]

Ethylene Oxide

[B139WV81000]

Ethylene Oxide

[B139WV81000]

Ethylene Oxide

[B139WV81000]

Ethylene Oxide

[B139WV81000]

Ethylene Oxide

[B139WV81000]

Ethylene Oxide

[B139WV81000]

Ethylene Oxide

[B139WV81000]

Ethylene Oxide

[B139WV81000]

Ethylene Oxide

[B139WV81000]

Ethylene Oxide

[B139WV81000]

Ethylene Oxide

[B139WV81000]

Ethylene Oxide

[B139WV81000]

Ethylene Oxide

[B139WV81000]

Ethylene Oxide

[B139WV81000]

Ethylene Oxide

[B139WV81000]

Ethylene Oxide

[B139WV81000]

Ethylene Oxide

[B139WV81000]

Ethylene Oxide

[B139WV81000]

Ethylene Oxide

[B139WV81000]

Ethylene Oxide

[B139WV81000]

Ethylene Oxide

[B139WV81000]

Ethylene Oxide

[B139WV81000]

Ethylene Oxide

[B139WV81000]

Ethylene Oxide

[B139WV81000]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-21

On-Brand Devices [JETi Peripheral Catheter]

• B139WV81000: WV8100
• WV6120US1: WV6120-US
• WV6120OUS1: WV6120-OUS
• B139WV61201: WV6120
• B139WV008F11: WV008F-1
• B139WV008F1: WV008F
• B139WV0006011: WV0006-01
• B139WV0006010: WV0006-01
• B139WV088F11: WV088F-1
• B139WV088F1: WV088F
• B139WV062F11: WV062F-1
• B139WV062F1: WV062F