Sync AV II Temporary Pacing Catheter— 510(k) K252042
Substantially EquivalentSwift Sync, Inc.
FDA 510(k) clearance K252042 for Sync AV II Temporary Pacing Catheter, Substantially Equivalent on 2026-07-30. Applicant: Swift Sync, Inc.. Device class: 2.
Summary
Swift Sync's Sync AV II Temporary Pacing Catheter is filed under LDF, temporary pacemaker electrodes. The record doesn't give the catheter's dimensions or electrode configuration.
Class II, 21 CFR 870.3680. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Swift Sync filed from Miami Shores, Florida. Review took 395 calendar days (June 30, 2025 to July 30, 2026).
Clearance details
- Applicant
- Swift Sync, Inc.
- Product code
- Product code LDF
- Device class
- Class 2
- Regulation
- 21 CFR 870.3680
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami Shores, FL, US
Recent devices under product code LDF
view all- K242863 — Bioptimal Bipolar Pacing Catheter
- K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
- K241334 — Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P) +4 more
- K241199 — Rotatable Connector (5944RL)
- K242705 — Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)
Adverse events under product code LDF
product code LDF- Death
- 19
- Injury
- 188
- Malfunction
- 694
- Other
- 1
- Total
- 902
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.