Home › Philips Image Guided Therapy Corporation › Stellarex 0.035" OTW drug-coated angioplasty balloon
Stellarex 0.035" OTW drug-coated angioplasty balloon
Philips Image Guided Therapy Corporation · Model AB35SX060100135 · UDI-DI 00810060550366
ONU
Prescription
0
510(k) clearances
5,888
Adverse events (528 deaths)
1
Recalls
26
Facilities
Description
6mm x 100mm x 135cm
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.