K232662
- 510(k) number
- K232662
- Device name
- BNLE Hydrophilic Jacketed Peripheral Guidewire
- Applicant
- Biomerics Nle MN · US
- Product code
- DQX — Wire, Guide, Catheter
- Decision date
- 2024-05-14
- Date received
- 2023-08-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K232662.pdf
Official FDA record: K232662
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.