Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)

K-Number: K251186 · 2025-05-15

ApplicantC.R. Bard, Inc.
Decision Date2025-05-15
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2025-05-15 under 510(k) number K251186. 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 Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)?

Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) is a medical device that received FDA 510(k) clearance on 2025-05-15. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K251186.

When did Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) receive FDA 510(k) clearance?

Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) received FDA 510(k) clearance on 2025-05-15, under 510(k) number K251186.

Who is the listed applicant for Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)?

The FDA product code for Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) is LDF.

Related Clinical Trials

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.

NCT03911700Prophylactic Reinforcement of Ventral Abdominal Incisions TrialRECRUITINGNCT04634916Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF SystemRECRUITINGNCT05711316The BD Liverty™ TIPS Stent Graft StudyACTIVE_NOT_RECRUITINGNCT05945329Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant AugmentationRECRUITINGNCT07282860An Evaluation of the PureWick™ Male External Catheter Versus an Established Comparator Overnight in the Home Setting for Incontinence in Adult MalesCOMPLETEDNCT07744945Evaluation of Male and Female External Catheters for Urine Output Monitoring in the ICUNOT_YET_RECRUITING

Other records listing C.R. Bard, Inc. as applicant

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.

PMA P800002Agent, absorbable hemostatic, collagen basedK253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)PMA P170042System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatmentK254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitK252971Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)K251864Rubber Utility Catheter

View all 74 devices →

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.

K252042Sync AV II Temporary Pacing CatheterSwift Sync, Inc.K242863Bioptimal Bipolar Pacing CatheterBioptimal International Pte. , Ltd.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.

↑