CADD®- Solis Ambulatory Infusion Pump With Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM)

Pump, Infusion, Pca

Smiths Medical ADS, Inc.

The following data is part of a premarket notification filed by Smiths Medical Ads, Inc. with the FDA for Cadd®- Solis Ambulatory Infusion Pump With Wireless Communication; Cadd®-solis Infusion Pump, Model 2110; Pharmguard® Administrator Medication Safety Software; Cadd® Administration Sets; Wireless Communication Module (cm).

Pre-market Notification Details

• Device ID: K170982
• 510k Number: K170982
• Device Name: CADD®- Solis Ambulatory Infusion Pump With Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM)
• Classification: Pump, Infusion, Pca
• Applicant: Smiths Medical ADS, Inc. 6000 Nathan Lane North Minneapolis, MN 55442
• Contact: Breanna Fautsch
• Correspondent: Breanna Fautsch; Smiths Medical ADS, Inc. 6000 Nathan Lane North Minneapolis, MN 55442
• Product Code: MEA
• Subsequent Product Code: FPA
• Subsequent Product Code: MRZ
• Subsequent Product Code: PYR
• CFR Regulation Number: 880.5725 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-04-03
• Decision Date: 2017-08-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15019517101041	K170982	000
15019517154894	K170982	000
15019517154887	K170982	000
15019517154290	K170982	000
15019517171969	K170982	000
15019517165753	K170982	000
15019517197112	K170982	000
15019517155006	K170982	000
15019517154986	K170982	000
10610586043628	K170982	000
15019517154993	K170982	000
15019517155013	K170982	000
15019517101034	K170982	000
15019517101027	K170982	000
15019517101010	K170982	000
15019517101003	K170982	000
15019517099690	K170982	000
15019517081282	K170982	000
15019517081275	K170982	000
15019517173864	K170982	000
15019517155020	K170982	000
15019517375244	K170982	000