ADD-VANTAGE ADDAPTOR

Set, I.v. Fluid Transfer

HOSPIRA, INC.

The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Add-vantage Addaptor.

Pre-market Notification Details

• Device ID: K133602
• 510k Number: K133602
• Device Name: ADD-VANTAGE ADDAPTOR
• Classification: Set, I.v. Fluid Transfer
• Applicant: HOSPIRA, INC. 375 N FIELD DRIVE Lake Forest, IL 60045
• Contact: Karen Keener
• Correspondent: Karen Keener; HOSPIRA, INC. 375 N FIELD DRIVE Lake Forest, IL 60045
• Product Code: LHI
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-11-25
• Decision Date: 2014-01-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30887787001670	K133602	000