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LUTONIX® Drug Coated Balloon
LUTONIX, INC. · Model BSLX351304405F · UDI-DI 00801741123733
ONU
Prescription
0
510(k) clearances
5,888
Adverse events (528 deaths)
1
Recalls
26
Facilities
Description
BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x40mm 5 French
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-03-23 | Medtronic Vascular, Inc. | Packaging for Balloon Catheters may be damaged resulting in loss of sterility. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.