Chemfort CSTD— 510(k) K192866
Substantially EquivalentSimplivia Healthcare , Ltd.
FDA 510(k) clearance K192866 for Chemfort CSTD, Substantially Equivalent on 2020-05-07. Applicant: Simplivia Healthcare , Ltd.. Device class: 2.
Clearance details
- Applicant
- Simplivia Healthcare , Ltd.
- 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
- Abbreviated
- Location
- Kiryat Shmona, IL
Recent devices under product code ONB
view all- K251722 — ProSeal Transfer Injector (421120, 421130, 421140)
- K253033 — Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor
- K250059 — BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O)
- K251411 — Chemfort Female Luer Lock Adaptor
- K251340 — ProSeal Bag Spike with Additive Port (423370ST, 423370)
More clearances from Simplivia Healthcare , Ltd.
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 →
Recalls naming K192866
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 K192866.
Data sourced from openFDA. This site is unofficial and independent of the FDA.