ARTLINE

Catheter, Percutaneous

HEALTH LINE INTERNATIONAL CORPORATION

The following data is part of a premarket notification filed by Health Line International Corporation with the FDA for Artline.

Pre-market Notification Details

• Device ID: K160448
• 510k Number: K160448
• Device Name: ARTLINE
• Classification: Catheter, Percutaneous
• Applicant: HEALTH LINE INTERNATIONAL CORPORATION 5675 WEST 300 SOUTH Salt Lake City, UT 84101
• Contact: Joel Faulkner
• Correspondent: Joel Faulkner; HEALTH LINE INTERNATIONAL CORPORATION 5675 WEST 300 SOUTH Salt Lake City, UT 84101
• Product Code: DQY
• CFR Regulation Number: 870.1250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-02-18
• Decision Date: 2016-07-12
• Summary: summary