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: K190604
• 510k Number: K190604
• Device Name: PIVO
• Classification: Tubes, Vials, Systems, Serum Separators, Blood Collection
• Applicant: Velano Vascular 221 Pine St #200 San Francisco, CA 94104
• Contact: Tiffini Wittwer
• Correspondent: Tiffini Wittwer; Velano Vascular 221 Pine St #200 San Francisco, CA 94104
• Product Code: JKA
• CFR Regulation Number: 862.1675 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-03-08
• Decision Date: 2019-05-13
• Summary: summary