Home › BrosMed Medical Co.,Ltd. › Tri-Wedge PTA Scoring Balloon Dilatation Catheter
Tri-Wedge PTA Scoring Balloon Dilatation Catheter
BrosMed Medical Co.,Ltd. · Model rev 01 · UDI-DI 06958481465327
10
510(k) clearances
2,083
Adverse events (2 deaths)
3
Recalls
34
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-05-24 | Cook Inc. | Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in t |
| 2019-05-24 | Cook Inc. | Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in t |
| 2019-05-24 | Cook Inc. | Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in t |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.