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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
- K243080Riptide Aspiration System2Cleared 510(K)
- K241221CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set2Cleared 510(K)
- K240917Esperance 3+ Aspiration Catheter System2Cleared 510(K)
- K242504Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set2Cleared 510(K)
- K234083Next Generation Aspiration Catheter; Balt Aspiration Tubing Set2Cleared 510(K)
- K233329Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set2Cleared 510(K)
- K232971APRO 55 Catheter and Alembic Aspiration Tubing2Cleared 510(K)
- K233988Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set2Cleared 510(K)
- K232524Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set2Cleared 510(K)
- K223913Socrates Aspiration System2Cleared 510(K)
Show All 88 Submissions
- NUIUltrasound, Infusion, System2Product Code
- QBECranial Sound Monitor2Product Code
- QJPCatheter, Percutaneous, Neurovasculature2Product Code
- 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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Next Generation Aspiration Catheter; Balt Aspiration Tubing Set
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K234083
- 510(k) Type
- Traditional
- Applicant
- Balt USA, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/2/2024
- Days to Decision
- 193 days
- Submission Type
- Summary