VERSASAE PLASTIC CANNULA- 11 GAUGE

Set, Administration, Intravascular

IMED CORP.

The following data is part of a premarket notification filed by Imed Corp. with the FDA for Versasae Plastic Cannula- 11 Gauge.

Pre-market Notification Details

• Device ID: K945070
• 510k Number: K945070
• Device Name: VERSASAE PLASTIC CANNULA- 11 GAUGE
• Classification: Set, Administration, Intravascular
• Applicant: IMED CORP. 9775 BUSINESSPARK AVE. San Diego, CA 92131 -1699
• Contact: Ahmad Sajadi
• Correspondent: Ahmad Sajadi; IMED CORP. 9775 BUSINESSPARK AVE. San Diego, CA 92131 -1699
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-10-14
• Decision Date: 1995-01-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20885403226073	K945070	000
37613203009523	K945070	000
50885403238565	K945070	000