XactTS Steerable Transseptal Catheter

GUDID 00850020653003

KEYSTONE HEART LTD

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

• Primary Device ID: 00850020653003
• NIH Device Record Key: 39c83b9b-00b5-4fee-a25d-72c5968f6938
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XactTS Steerable Transseptal Catheter
• Version Model Number: SS-001
• Company DUNS: 649822251
• Company Name: KEYSTONE HEART LTD
• 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

Device Dimensions

• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850020653003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202226

FDA Product Code

• DYB: Introducer, Catheter

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: 2021-04-01
• Device Publish Date: 2021-03-24