ZAVATION ZVplasty Balloon Catheter

GUDID 00197157026646

10G, 20MM ZVplasty Balloon Catheter

Zavation LLC

Balloon kyphoplasty kit

• Primary Device ID: 00197157026646
• NIH Device Record Key: 1307ce1f-8705-4355-a2a8-9fe22bd281ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZAVATION ZVplasty Balloon Catheter
• Version Model Number: VCF-1020-FLEX-1
• Company DUNS: 069472800
• Company Name: Zavation LLC
• 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: false
• 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: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com
• Phone: 6019191119
• Email: info@zavation.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197157026646 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141419

FDA Product Code

• NDN: Cement, Bone, Vertebroplasty

Sterilization

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

[00197157026646]

Ethylene Oxide

[00197157026646]

Ethylene Oxide

[00197157026646]

Ethylene Oxide

[00197157026646]

Ethylene Oxide

[00197157026646]

Ethylene Oxide

[00197157026646]

Ethylene Oxide

[00197157026646]

Ethylene Oxide

[00197157026646]

Ethylene Oxide

[00197157026646]

Ethylene Oxide

[00197157026646]

Ethylene Oxide

[00197157026646]

Ethylene Oxide

[00197157026646]

Ethylene Oxide

[00197157026646]

Ethylene Oxide

[00197157026646]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-16
• Device Publish Date: 2025-07-08

On-Brand Devices [ZAVATION ZVplasty Balloon Catheter]

• 00197157026646: 10G, 20MM ZVplasty Balloon Catheter
• 00197157026639: 10G, 15MM ZVplasty Balloon Catheter