D·Kutting LL Peripheral Scoring Balloon Dilatation Catheter— 510(k) K242254
Substantially EquivalentDk Medical Technology Co., Ltd.
FDA 510(k) clearance K242254 for D·Kutting LL Peripheral Scoring Balloon Dilatation Catheter, Substantially Equivalent on 2025-04-21. Applicant: Dk Medical Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Dk Medical Technology 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
- Jiangsu, CN
Recent devices under product code PNO
view all- K260012 — UltraScore Focused Force PTA Balloon
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- K241478 — Tri-Wedge PTA 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 Dk Medical Technology 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.