lntravascular Administration Sets with Stopcock and Manifold— 510(k) K223175
Substantially EquivalentBaxter Healthcare Corporation
FDA 510(k) clearance K223175 for lntravascular Administration Sets with Stopcock and Manifold, Substantially Equivalent on 2023-03-10. Applicant: Baxter Healthcare Corporation. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corporation
- Product code
- Code FMG
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Round Lake, IL, US
Recent devices under product code FMG
view all- K242255 — Qitexio® 4-Way Stopcock (QIT014)
- K223499 — Three Way Stop Cock
- K211204 — SafePort(TM) Manifold (or Stopcock)
- K210516 — Clicky Cross
- K190539 — TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile
More clearances from Baxter Healthcare Corporation
view all- K251745 — Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
- K251636 — Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
- K251640 — SIGMA Spectrum Infusion Pump with Master Drug Library
- K243529 — Solution Administration Sets
- K242339 — Intravascular Extension Sets and Accessories
Adverse events under product code FMG
product code FMG- Death
- 14
- Malfunction
- 3,433
- Other
- 1
- Total
- 3,448
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.