CADD® Infusion Disposables Portfolio With NRFit™ Connectors

Administrations Sets With Neuraxial Connectors

Smiths Medical ASD, Inc.

The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Cadd® Infusion Disposables Portfolio With Nrfit™ Connectors.

Pre-market Notification Details

• Device ID: K162219
• 510k Number: K162219
• Device Name: CADD® Infusion Disposables Portfolio With NRFit™ Connectors
• Classification: Administrations Sets With Neuraxial Connectors
• Applicant: Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442
• Contact: Wendy J. Kivens
• Correspondent: Michael Johnson; Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442
• Product Code: PWH
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-08-08
• Decision Date: 2017-07-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
35019517184253	K162219	000
30610586043837	K162219	000
30610586043844	K162219	000
30610586043974	K162219	000
30610586043998	K162219	000
30610586044001	K162219	000
30610586044018	K162219	000
30610586044025	K162219	000
30610586044117	K162219	000
30610586044742	K162219	000
30610586044759	K162219	000
35019517184246	K162219	000
30610586043820	K162219	000