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 |
| 35019517184246 | K162219 | 000 |
| 30610586044759 | K162219 | 000 |
Trademark Results [CADD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CADD 85113149 4025048 Dead/Cancelled |
Smiths Medical ASD, Inc. 2010-08-23 |
 CADD 78847519 3201977 Live/Registered |
SMITHS MEDICAL ASD, INC. 2006-03-28 |
 CADD 75656568 2554554 Dead/Cancelled |
NOBEL BIOCARE AB 1999-03-08 |
 CADD 73751005 1547216 Live/Registered |
PHARMACIA DELTEC, INC. 1988-09-07 |
 CADD 73661271 1686787 Dead/Cancelled |
AUDIO ANALYSTS INC. 1987-05-18 |
 CADD 73062204 1070788 Dead/Cancelled |
Ready Stamping System Inc. 1975-09-05 |
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