Tri-Wedge PTA Scoring Balloon Dilatation Catheter— 510(k) K241478
Substantially EquivalentBrosmed Medical Co., Ltd.
FDA 510(k) clearance K241478 for Tri-Wedge PTA Scoring Balloon Dilatation Catheter, Substantially Equivalent on 2024-10-22. Applicant: Brosmed Medical Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Brosmed Medical Co., Ltd.
- Product code
- Code PNO
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dongguan, CN
Recent devices under product code PNO
view all- K260012 — UltraScore Focused Force PTA Balloon
- K243944 — Aperta NSE PTA Balloon Dilatation Catheter
- K242254 — D·Kutting LL Peripheral Scoring Balloon Dilatation Catheter
- K232258 — XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter
- K232013 — Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)
More clearances from Brosmed Medical Co., Ltd.
view allAdverse events under product code PNO
product code PNO- Malfunction
- 1,646
- Total
- 1,646
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.