Diana Medication Transfer Set— 510(k) K170110
Substantially EquivalentIcu Medical, Inc.
FDA 510(k) clearance K170110 for Diana Medication Transfer Set, Substantially Equivalent on 2018-08-10. Applicant: Icu Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Icu Medical, Inc.
- Product code
- Code ONB
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Clemente, CA, US
Recent devices under product code ONB
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- K251340 — ProSeal Bag Spike with Additive Port (423370ST, 423370)
More clearances from Icu Medical, Inc.
view allAdverse events under product code ONB
product code ONB- Malfunction
- 3,615
- Other
- 13
- Total
- 3,628
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.