Ringer perfusion balloon catheter, 2.00 x 20mm (5881) +8 more— 510(k) K233729

Clearance details

Device name as filed

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

Code LOX

Device class

Class 2

Regulation

21 CFR 870.5100

Advisory panel

Cardiovascular

Date received

2023-11-21

Decision date

2024-05-31

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Minneapolis, MN, US

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Death

190

Injury

1,498

Malfunction

9,670

Total

11,358

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →