Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- 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
- K242051VersaD Delivery Catheter2Cleared 510(K)
- K243577Radical the Dude 8F Guide Catheter2Cleared 510(K)
- K243297APRO 70 Swift Catheter2Cleared 510(K)
- K242376Next Generation Access Platform2Cleared 510(K)
- K241768Broadway 8 Catheter (BRW084132-01)2Cleared 510(K)
- K241637Echo Intracranial Base Catheter2Cleared 510(K)
- K242033Access25™ Delivery Microcatheter2Cleared 510(K)
- K24097187 NeuGlide Catheter2Cleared 510(K)
- K242301Socrates 38 Catheter2Cleared 510(K)
- K240746Neurovascular Access System Family2Cleared 510(K)
Show All 70 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
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Next Generation Access Platform
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K242376
- 510(k) Type
- Traditional
- Applicant
- Balt USA, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/30/2024
- Days to Decision
- 143 days
- Submission Type
- Summary