Decision Date2026-07-30
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Sync AV II Temporary Pacing Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Swift Sync, Inc.. It received FDA 510(k) clearance on 2026-07-30 under 510(k) number K252042. The device is classified under product code LDF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sync AV II Temporary Pacing Catheter?
Sync AV II Temporary Pacing Catheter is a medical device that received FDA 510(k) clearance on 2026-07-30. The listed applicant is Swift Sync, Inc.. The 510(k) number is K252042.
When did Sync AV II Temporary Pacing Catheter receive FDA 510(k) clearance?
Sync AV II Temporary Pacing Catheter received FDA 510(k) clearance on 2026-07-30, under 510(k) number K252042.
Who is the listed applicant for Sync AV II Temporary Pacing Catheter?
The FDA 510(k) record lists Swift Sync, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sync AV II Temporary Pacing Catheter?
The FDA product code for Sync AV II Temporary Pacing Catheter is LDF.
Related Devices (Code: LDF)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
K242863Bioptimal Bipolar Pacing CatheterBioptimal International Pte. , Ltd.K251186Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)C.R. Bard, Inc.K241334Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter,C.R. Bard, Inc.K241199Rotatable Connector (5944RL)Shenzhen Launch Electrical Co., Ltd.K242705Streamline 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)Medtronic, Inc.K232261TME Temporary Myocardial ElectrodeOsypka AG
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.