510(k) K252042
K252042 is an FDA 510(k) premarket notification submitted by Swift Sync, Inc. for the device "Sync AV II Temporary Pacing Catheter". The FDA issued a decision of Substantially Equivalent on July 30, 2026. The device falls under product code LDF (Electrode, Pacemaker, Temporary), a Class II device regulated under 21 CFR 870.3680.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 2026
- Date Received
- June 30, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Pacemaker, Temporary
- Device Class
- Class II
- Regulation Number
- 870.3680
- Review Panel
- CV
- Submission Type