FDA 510(k)

Medline Reinforced Epidural Catheter

Número K: K181782 · 2019-03-04

Data da decisão2019-03-04

Código do produtoBSO

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medline Reinforced Epidural Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2019-03-04 under 510(k) number K181782. The device is classified under product code BSO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Medline Reinforced Epidural Catheter?

Medline Reinforced Epidural Catheter is a medical device that received FDA 510(k) clearance on 2019-03-04. The listed applicant is Medline Industries, Inc.. The 510(k) number is K181782.

When did Medline Reinforced Epidural Catheter receive FDA 510(k) clearance?

Medline Reinforced Epidural Catheter received FDA 510(k) clearance on 2019-03-04, under 510(k) number K181782.

Who is the listed applicant for Medline Reinforced Epidural Catheter?

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

What is the FDA product code for Medline Reinforced Epidural Catheter?

The FDA product code for Medline Reinforced Epidural Catheter is BSO.

Ensaios clínicos relacionados

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Medline Industries, Inc. como candidato(a)

K230559Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)K223100Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)K222665Medline UNITE® Ankle Fusion Plating System K213054Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe K212911Konig Mogen Clamp K220565Hudson RCI Triflo II Incentive Deep Breathing Exerciser

Ver todos os 74 dispositivos →

Dispositivos Relacionados (Código: BSO)

K241410EDEN ControlCathJmt Co., Ltd.K231242Perifix FX Catheter; Contiplex FX CatheterB.Braun Medical, Inc.K230603Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)Teleflex Medical K193664SubQKath Catheter and Needle SetHk Surgical K200624Percutaneous IntroducerEpimed International, Inc.K191470C-CAT Anaesthesia Catheter kitCimpax Aps

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.