Sniper SA-0090

GUDID B323SA00900

Infusion catheter with balloon occlusion

EMBOLX, INC.

Peripheral vascular infusion catheter

• Primary Device ID: B323SA00900
• NIH Device Record Key: 51337b0d-ced1-4df5-8774-1e490f9b6027
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sniper
• Version Model Number: SA-0090
• Catalog Number: SA-0090
• Company DUNS: 079084339
• Company Name: EMBOLX, 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B323SA00900 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142692

FDA Product Code

• MJN: Catheter, Intravascular Occluding, Temporary

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-09
• Device Publish Date: 2017-02-12

On-Brand Devices [Sniper]

• 00853359008056: The Sniper is a dual lumen, 110cm, straight tip catheter comprised of an inner guidewire/infusio
• 00853359008049: The Sniper is a dual lumen, 130cm, straight tip catheter comprised of an inner guidewire/infusio
• 00853359008032: The Sniper is a dual lumen, 150cm, straight tip catheter comprised of an inner guidewire/infusio
• 00853359008025: The Sniper is a dual lumen, 150cm, straight tip catheter comprised of an inner guidewire/infusio
• 00853359008018: The Sniper is a dual lumen, 130cm, straight tip catheter comprised of an inner guidewire/infusio
• 00853359008001: The Sniper is a dual lumen, 110cm, straight tip catheter comprised of an inner guidewire/infusio
• B323SA00900: Infusion catheter with balloon occlusion
• 00853359008414: The Sniper is a dual lumen, 165cm, straight tip catheter comprised of an inner guidewire/infusio