Data da decisão2025-05-15
Código do produtoLDF
Comité consultivoCV
DecisãoSubstantially Equivalent
Resumo do dispositivo
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.
Perguntas frequentes
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.
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Dispositivos Relacionados (Código: LDF)
Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.
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
Fonte oficial
Ver na base de dados da FDA →Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.