TRUE

Catheter, Angioplasty, Peripheral, Transluminal

INFINITY EXTRUSION & ENGINEERING, INC.

The following data is part of a premarket notification filed by Infinity Extrusion & Engineering, Inc. with the FDA for True.

Pre-market Notification Details

• Device ID: K993913
• 510k Number: K993913
• Device Name: TRUE
• Classification: Catheter, Angioplasty, Peripheral, Transluminal
• Applicant: INFINITY EXTRUSION & ENGINEERING, INC. 3350 SCOTT BLVD., BLDG.6 UNIT 601 Santa Clara, CA 95054
• Contact: Douglas Wilkins
• Correspondent: Douglas Wilkins; INFINITY EXTRUSION & ENGINEERING, INC. 3350 SCOTT BLVD., BLDG.6 UNIT 601 Santa Clara, CA 95054
• Product Code: LIT
• CFR Regulation Number: 870.1250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-11-17
• Decision Date: 2000-08-09
• Summary: summary