Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Manual Hematology DevicesCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart I—Hematology ReagentsCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
- BSAWarmer, Blood, Electromagnetic Radiation3Product Code
- BSBWarmer, Blood, Non-Electromagnetic Radiation2Product Code
- GKTSeparator, Automated, Blood Cell, Diagnostic2Product Code
- KSBSet, Transfer (Blood/Plasma)2Product Code
- KSDDevice, Heat-Sealing1Product Code
- KSERefrigerator, Freezer, Blood Storage2Product Code
- KSFKit, Quality Control For Blood Banking Reagents2Product Code
- KSGMedia, Potentiating For In Vitro Diagnostic Use2Product Code
- KSHChamber, Environmental For The Storage Of Platelet Concentrate2Product Code
- KSILectins And Protectins2Product Code
- KSKSolution, Stabilized Enzyme2Product Code
- KSLSolution, Copper Sulfate For Specific Gravity Determinations1Product Code
- KSMSystem, Test, Combs, Automated2Product Code
- KSNCentrifuge, Cell-Washing, Automated For Immuno-Hematology2Product Code
- KSOCentrifuge, Blood-Bank For In Vitro Diagnostic Use1Product Code
- KSPApparatus, Cell-Freezing And Reagents1Product Code
- KSQDevice, Blood Mixing And Blood Weighing1Product Code
- KSRContainer, Empty, For Collection & Processing Of Blood & Blood Components2Product Code
- K032827KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 565012Cleared 510(K)
- K020753DEROYAL SURGICAL, UMBILICUP2Cleared 510(K)
- K810897ALPHA PLASTIC PLASMA BOTTLE2Cleared 510(K)
- K810500BLOOD FREEZING BAG2Cleared 510(K)
- K811523PLASMA FLEX2Cleared 510(K)
- K811449HAEMONETICS 1000ML COMPONENT BAG2Cleared 510(K)
- K810711HAEMONETICS 600 ML. COMPONENT BAG2Cleared 510(K)
- K810313HAEMONETICS 1400 ML THERAPEUTIC BAG2Cleared 510(K)
- K801219PLASMAPOOLER2Cleared 510(K)
- K801082GAMBRO HEMOFREEZE-BAG2Cleared 510(K)
Show All 16 Submissions
- KSSSupplies, Blood-Bank1Product Code
- KSTSystem, Blood Collection, Vacuum-Assisted, Manual1Product Code
- KSWSystem, Processing For Frozen Blood2Product Code
- KSXSubstance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use2Product Code
- KSYBoxes, View, Blood Grouping1Product Code
- KSZSystem, Test, Automated Blood Grouping And Antibody2Product Code
- KZLDevice, Warming. Blood And Plasma2Product Code
- MMHBlood Establishment Computer Software And Accessories2Product Code
- MYJDevice, Mixing And Weighing, Semi-Automated2Product Code
- MYXSystem, Blood Collection, Vacuum-Assisted, Automated1Product Code
- OQXSelf-Contained Blood Grouping2Product Code
- ORGPlatelet And Plasma Separator For Bone Graft Handling2Product Code
- PBCManual Blood Grouping And Antibody Test Systems2Product Code
- PKGBone Marrow Processing Device To Support Hematopoietic Reconstitution2Product Code
- PMQPeripheral Blood Processing Device For Wound Management2Product Code
- QYCContainer System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions2Product Code
- Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)CFR Sub-Part
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
PLASMA FLEX
- Page Type
- Cleared 510(K)
- 510(k) Number
- K811523
- 510(k) Type
- Traditional
- Applicant
- TERUMO AMERICA, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/9/1981
- Days to Decision
- 103 days