VIA Microcatheter FGA17154-01

GUDID 00851566003925

VIA 17 Microcatheter

SEQUENT MEDICAL, 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

• Primary Device ID: 00851566003925
• NIH Device Record Key: ca9f7080-a2a7-4ec9-91b7-a4f2bf0b2591
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIA Microcatheter
• Version Model Number: VIA-17-154-01
• Catalog Number: FGA17154-01
• Company DUNS: 796807340
• Company Name: SEQUENT MEDICAL, 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com

Device Dimensions

• Lumen/Inner Diameter: 0.0175 Inch
• Lumen/Inner Diameter: 0.0175 Inch
• Lumen/Inner Diameter: 0.0175 Inch
• Lumen/Inner Diameter: 0.0175 Inch
• Lumen/Inner Diameter: 0.0175 Inch
• Lumen/Inner Diameter: 0.0175 Inch
• Lumen/Inner Diameter: 0.0175 Inch
• Lumen/Inner Diameter: 0.0175 Inch
• Lumen/Inner Diameter: 0.0175 Inch
• Lumen/Inner Diameter: 0.0175 Inch
• Lumen/Inner Diameter: 0.0175 Inch
• Lumen/Inner Diameter: 0.0175 Inch
• Lumen/Inner Diameter: 0.0175 Inch
• Lumen/Inner Diameter: 0.0175 Inch
• Lumen/Inner Diameter: 0.0175 Inch
• Lumen/Inner Diameter: 0.0175 Inch
• Lumen/Inner Diameter: 0.0175 Inch
• Lumen/Inner Diameter: 0.0175 Inch
• Lumen/Inner Diameter: 0.0175 Inch
• Lumen/Inner Diameter: 0.0175 Inch
• Lumen/Inner Diameter: 0.0175 Inch
• Lumen/Inner Diameter: 0.0175 Inch
• Lumen/Inner Diameter: 0.0175 Inch
• Lumen/Inner Diameter: 0.0175 Inch
• Lumen/Inner Diameter: 0.0175 Inch
• Lumen/Inner Diameter: 0.0175 Inch
• Lumen/Inner Diameter: 0.0175 Inch
• Lumen/Inner Diameter: 0.0175 Inch
• Lumen/Inner Diameter: 0.0175 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851566003925 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162565

FDA Product Code

• KRA: Catheter, Continuous Flush

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2019-08-15
• Device Publish Date: 2017-03-31

On-Brand Devices [VIA Microcatheter]

• 00851566003925: VIA 17 Microcatheter
• 00851566003918: VIA 21 Microcatheter
• 00851566003703: VIA 33 Microcatheter
• 00851566003420: VIA 27 Microcatheter