K252042
- 510(k) number
- K252042
- Device name
- Sync AV II Temporary Pacing Catheter
- Applicant
- Swift Sync, Inc. FL · US
- Product code
- LDF — Electrode, Pacemaker, Temporary
- Decision date
- 2026-07-30
- Date received
- 2025-06-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K252042.pdf
Official FDA record: K252042
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.