K231821
- 510(k) number
- K231821
- Device name
- XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)
- Applicant
- Transit Scientific, LLC UT · US
- Product code
- KRA — Catheter, Continuous Flush
- Decision date
- 2023-11-29
- Date received
- 2023-06-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K231821.pdf
Official FDA record: K231821
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.