K243224
- 510(k) number
- K243224
- Device name
- MitraClip G5 Steerable Guide Catheter (SGC0801); TriClip G5 Steerable Guide Catheter (TSGC0801)
- Applicant
- ABBOTT MEDICAL MN · US
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2024-12-31
- Date received
- 2024-10-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243224.pdf
Official FDA record: K243224
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.