Vascular Solutions, LLC · Class II · Cleared May 31, 2024
| 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 |
| Product code | LOX |
| Device class | Class II |
| Decision date | May 31, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 870.5100 |
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