K242824
- 510(k) number
- K242824
- Device name
- PTFE Guidewire
- Applicant
- Lake Region Medical MN · US
- Product code
- DQX — Wire, Guide, Catheter
- Decision date
- 2024-12-06
- Date received
- 2024-09-18
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K242824.pdf
Official FDA record: K242824
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.