20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)

Tubes, Vials, Systems, Serum Separators, Blood Collection

AVIA Vascular

The following data is part of a premarket notification filed by Avia Vascular with the FDA for 20g Open-system Ally Device Kit (av100000), 22g Open-system Ally Device Kit (av110000).

Pre-market Notification Details

• Device ID: K220258
• 510k Number: K220258
• Device Name: 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)
• Classification: Tubes, Vials, Systems, Serum Separators, Blood Collection
• Applicant: AVIA Vascular 6030 W Harold Gatty Dr. Salt Lake City, UT 84116
• Contact: Kevin Cook
• Correspondent: Jonathan Holmes; MedVenture Health 299 S Main Street, Suite 2300 Salt Lake City, UT 84111
• Product Code: JKA
• CFR Regulation Number: 862.1675 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-01-31
• Decision Date: 2022-07-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850042365014	K220258	000
00850042365007	K220258	000