K231629
- 510(k) number
- K231629
- Device name
- 091 Balloon Guide Catheter
- Applicant
- Eosolutions, Corp. FL · US
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2023-10-31
- Date received
- 2023-06-05
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K231629.pdf
Official FDA record: K231629
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.