PIVO

Tubes, Vials, Systems, Serum Separators, Blood Collection

Velano Vascular

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

Pre-market Notification Details

• Device ID: K163508
• 510k Number: K163508
• Device Name: PIVO
• Classification: Tubes, Vials, Systems, Serum Separators, Blood Collection
• Applicant: Velano Vascular 1756 Fillmore St. San Francisco, CA 94115
• Contact: Tiffini Diage
• Correspondent: Tiffini Diage; Velano Vascular 1756 Fillmore St. San Francisco, CA 94115
• Product Code: JKA
• CFR Regulation Number: 862.1675 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-12-14
• Decision Date: 2017-02-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850984007034	K163508	000
00850984007027	K163508	000