Anesthesiology
Review Panel
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- ChemistryReview Panel
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- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- MOFGuide, Wire, Catheter, Neurovasculature2Product Code
- NDQSystem, Catheter Or Guidewire, Steerable (Magnetic)2Product Code
- NRYCatheter, Thrombus Retriever2Product Code
- NUIUltrasound, Infusion, System2Product Code
- QBECranial Sound Monitor2Product Code
- QJPCatheter, Percutaneous, Neurovasculature2Product Code
- K251372VersaD Delivery Catheter2Cleared 510(K)
- K252569Carrier XL Delivery Catheter2Cleared 510(K)
- K250960DUO Microcatheter2Cleared 510(K)
- K251560FUBUKI XF-R Neurovascular Long Sheath2Cleared 510(K)
- K251240Branchor X Balloon Guide Catheter2Cleared 510(K)
- K25104493 NeuFlex Catheter2Cleared 510(K)
- K242392PATH BGC2Cleared 510(K)
- K242289Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter2Cleared 510(K)
- K243593AXS Lift Intracranial Base Catheter2Cleared 510(K)
- K242051VersaD Delivery Catheter2Cleared 510(K)
Show All 80 Submissions
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular 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
- Obstetrical and GynecologicalReview Panel
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- General and Plastic SurgeryReview Panel
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- Medical GeneticsReview Panel
- UnknownReview Panel
VersaD Delivery Catheter
- Page Type
- Cleared 510(K)
- 510(k) Number
- K242051
- 510(k) Type
- Traditional
- Applicant
- Unity Medical, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/17/2025
- Days to Decision
- 189 days
- Submission Type
- Summary