TIVA

Tubes, Vials, Systems, Serum Separators, Blood Collection

Velano Vascular, Inc.

The following data is part of a premarket notification filed by Velano Vascular, Inc. with the FDA for Tiva.

Pre-market Notification Details

• Device ID: K142946
• 510k Number: K142946
• Device Name: TIVA
• Classification: Tubes, Vials, Systems, Serum Separators, Blood Collection
• Applicant: Velano Vascular, Inc. 1500 Locust St Suite 4311 Philadelphia, PA 19102
• Contact: Tiffini Diage
• Correspondent: Tiffini Diage; Velano Vascular, Inc. 1500 Locust St Suite 4311 Philadelphia, PA 19102
• Product Code: JKA
• CFR Regulation Number: 862.1675 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-10-10
• Decision Date: 2015-01-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10850984007000	K142946	000