Home › Shenzhen Shineyard Medical Device Co.,Ltd. › Matreneu® Percutaneous Balloon Compression Kit
Matreneu® Percutaneous Balloon Compression Kit
Shenzhen Shineyard Medical Device Co.,Ltd. · Model PBCS-088014 · UDI-DI 06939698601302
HAO
Prescription
1
510(k) clearances
351
Adverse events
2
Recalls
211
Facilities
Description
This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-04-04 | Zimmer Inc. | A rounded or partially rounded tip on the screwdriver may not provide the required locking torque to lock the closure top to the polyaxial screw. When the hex tip of the screwdrive |
| 2010-07-02 | Integra LifeSciences Corp | Certain NeuroBalloon Catheters have the potential to improperly inflate or deflate under certain conditions. |
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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.