Anesthesiology
Review Panel
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- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- DQFActuator, Syringe, Injector Type2Product Code
- DQIWithdrawal/Infusion Pump2Product Code
- DXTInjector And Syringe, Angiographic2Product Code
- K242143Angiography Injector2Cleared 510(K)
- K242212Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)2Cleared 510(K)
- K241109Single-use Sterile High-pressure Angiographic Syringes and Accessories2Cleared 510(K)
- K230668Disposable High-pressure Extension Lines2Cleared 510(K)
- K232388High Pressure Tubing2Cleared 510(K)
- K211564Sterile High-pressure Angiographic Syringes for Single-use2Cleared 510(K)
- K203004ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System2Cleared 510(K)
- K201395Sterile High-pressure Angiographic Syringes for single-use2Cleared 510(K)
- K192657Sterile High-pressure Angiographic Syringes for Single-use2Cleared 510(K)
- K192370MEDRAD Stellant FLEX CT Injection System with Certegra Workstation2Cleared 510(K)
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- IZQInjector, Contrast Medium, Automatic2Product Code
- NKPInjector, Contrast Medium, Automatic, Reprocessed2Product Code
- NKTInjector And Syringe, Angiographic, Reprocessed2Product Code
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
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MEDRAD Stellant FLEX CT Injection System with Certegra Workstation
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K192370
- 510(k) Type
- Traditional
- Applicant
- Bayer Medical Care, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/13/2019
- Days to Decision
- 105 days
- Submission Type
- Summary