K231402
- 510(k) number
- K231402
- Device name
- HP PTA Balloon Dilatation Catheter
- Applicant
- Kossel Medtech (Suzhou) Co., Ltd. CN
- Product code
- LIT — Catheter, Angioplasty, Peripheral, Transluminal
- Decision date
- 2023-12-20
- Date received
- 2023-05-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K231402.pdf
Official FDA record: K231402
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.