K233729
- 510(k) number
- K233729
- Device name
- Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58
- Applicant
- Vascular Solutions, LLC MN · US
- Product code
- LOX — Catheters, Transluminal Coronary Angioplasty, Percut
- Decision date
- 2024-05-31
- Date received
- 2023-11-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K233729.pdf
Official FDA record: K233729
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.