CADD Yellow High Volume Administration Set with NRFit connector
FDA 510(k) clearance K172592 · decided 2018-05-17
Clearance details
- K-number
- K172592
- Device name
- CADD Yellow High Volume Administration Set with NRFit connector
- Applicant
- Smiths Medical Asd, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-08-29
- Decision date
- 2018-05-17
- Days to decision
- 261 days
- Clearance type
- Traditional
- Product code
- PWH
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BD Alaris™ Pump Epidural Infusion Set (K221319) | Care Fusion | 2023-07-21 |
| PCEA Syringe Set (K211649) | Baxter Healthcare Corporation | 2021-11-23 |
| CADD® Infusion Disposables Portfolio with NRFit™ connectors (K162219) | Smiths Medical Asd, Inc. | 2017-07-20 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S018) | Smiths Medical Asd, Inc. | 2013-05-13 |
| PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S017) | Smiths Medical Asd, Inc. | 2010-04-21 |
| PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM AND PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S016) | Smiths Medical Asd, Inc. | 2009-04-20 |
| PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S015) | Smiths Medical Asd, Inc. | 2007-11-06 |
| PORT-A-CATH EPIDURAL & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS (P900052/S014) | Smiths Medical Asd, Inc. | 2007-08-28 |
| PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S013) | Smiths Medical Asd, Inc. | 2007-04-05 |
| PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM, PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM (P900052/S012) | Smiths Medical Asd, Inc. | 2002-12-17 |
| PORT-A-CATH EPIDURAL/PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS (P900052/S011) | Smiths Medical Asd, Inc. | 2002-10-03 |