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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
- K240746Neurovascular Access System Family2Cleared 510(K)
- K240711Zipline Access Catheter2Cleared 510(K)
- K241244CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter2Cleared 510(K)
- K2405298F Modified Sheath System2Cleared 510(K)
- K234074Next Generation Access Catheter2Cleared 510(K)
- K240948TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support2Cleared 510(K)
- K232542Wedge XL Delivery Catheter2Cleared 510(K)
- K233982CEREGLIDE 92 Catheter System2Cleared 510(K)
- K233924EMBOGUARD Balloon Guide Catheter2Cleared 510(K)
- K233201MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)2Cleared 510(K)
Show All 61 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
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EMBOGUARD Balloon Guide Catheter
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K233924
- 510(k) Type
- Special
- Applicant
- Neuravi Limited
- Country
- Ireland
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/18/2024
- Days to Decision
- 127 days
- Submission Type
- Summary