CADD® Infusion Disposables Portfolio with NRFit connectors— 510(k) K162219
Substantially EquivalentSmiths Medical Asd, Inc.
FDA 510(k) clearance K162219 for CADD® Infusion Disposables Portfolio with NRFit connectors, Substantially Equivalent on 2017-07-20. Applicant: Smiths Medical Asd, Inc.. Device class: 2.
Clearance details
- Applicant
- Smiths Medical Asd, Inc.
- Product code
- Code PWH
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Recent devices under product code PWH
view allMore clearances from Smiths Medical Asd, Inc.
view all- K232943 — Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space Syringe
- K210833 — Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula
- K211634 — Hypodermic Needle-Pro EDGE Safety Device
- K192375 — Intellifuse Administration and Intellifuse Blood Administration Sets
- K181699 — Level 1 Convective Warmer
Adverse events under product code PWH
product code PWH- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K162219
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162219.
Data sourced from openFDA. This site is unofficial and independent of the FDA.