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Luminscan(TM) Disposable Imaging Kit
Micro-Tech (Nanjing) Co., Ltd. · Model BOP-16-30-25-7 · UDI-DI 06932503570022
NQQ
Prescription
1
510(k) clearances
69
Adverse events
3
Recalls
26
Facilities
Description
The diameter of the balloon is 16mm, the effective length is 30mm, the outer diameter of the Balloon catheter is 7Fr, and the length of the probe is 2500mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-04-11 | Ninepoint Medical Inc. | Distal tips of the probes may detach from the probe shaft during use. |
| 2011-12-22 | Imalux Corporation | During an FDA inspection, the firm was notified that the wrong tubing was used during the manufacture of the probe for the unit. |
| 2010-07-20 | Optovue Inc. | Use of the CAM attachment may result in a positioning anomaly and mistreatment in the eyes of the patient. |
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