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Ringer perfusion balloon catheter, 2.00 x 20mm (5881) +8 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K233729

by Vascular Solutions, LLC

Identifiers

510(k) Number
K233729 FDA 510(k)
FDA Product Code
LOX FDA 510(k)
Models / Variants
Ringer perfusion balloon catheter, 2.00 x 20mm (5881) FDA 510(k)
Ringer perfusion balloon catheter, 2.50 x 20mm (5882) FDA 510(k)
Ringer perfusion balloon catheter, 2.50 x 30mm (5883) FDA 510(k)
Ringer perfusion balloon catheter, 3.00 x 20mm (5884) FDA 510(k)
Ringer perfusion balloon catheter, 3.00 x 30mm (5885) FDA 510(k)
Ringer perfusion balloon catheter, 3.50 x 20mm (5886) FDA 510(k)
Ringer perfusion balloon catheter, 3.50 x 30mm (5887) FDA 510(k)
Ringer perfusion balloon catheter, 4.00 x 20mm (5888) FDA 510(k)
Ringer perfusion balloon catheter, 4.00 x 30mm (58 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.5100 FDA 510(k)
Regulation Number
870.5100 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Ringer perfusion balloon catheter, 2.00 x 20mm (5881) +8 more models by Vascular Solutions, LLC — Class II — FDA_510K — listed in FDA 510(k) — 9 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Vascular Solutions, LLC

Sources (1)

  • FDA 510(k) K233729 24 fields · synced Jun 19, 2026