ViperCath XC 7-10043-01

GUDID 10852528005688

200 cm, 0.035" guidewire compatible, support catheter

Cardiovascular Systems, Inc.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use

• Primary Device ID: 10852528005688
• NIH Device Record Key: 8b77d92b-9964-4a14-9186-5446a94d34e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ViperCath XC
• Version Model Number: 035-XC-200-0
• Catalog Number: 7-10043-01
• Company DUNS: 024954518
• Company Name: Cardiovascular Systems, 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

Customer Support Contacts

• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10852528005688 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183000

FDA Product Code

• DQY: Catheter, Percutaneous

Sterilization

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

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

[10852528005688]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-07-23
• Device Publish Date: 2019-02-04

On-Brand Devices [ViperCath XC]

• 10852528005695: 200 cm, 0.035" guidewire compatible, support catheter
• 10852528005688: 200 cm, 0.035" guidewire compatible, support catheter