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FDA 510(k)

TE ME NA EPIDURAL CATHETER

K-Number: K991259 · 2001-02-21

ApplicantTe ME NA S.A.R.L.
Decision Date2001-02-21
Product CodeBSO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TE ME NA EPIDURAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Te ME NA S.A.R.L.. It received FDA 510(k) clearance on 2001-02-21 under 510(k) number K991259. The device is classified under product code BSO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TE ME NA EPIDURAL CATHETER?

TE ME NA EPIDURAL CATHETER is a medical device that received FDA 510(k) clearance on 2001-02-21. The listed applicant is Te ME NA S.A.R.L.. The 510(k) number is K991259.

When did TE ME NA EPIDURAL CATHETER receive FDA 510(k) clearance?

TE ME NA EPIDURAL CATHETER received FDA 510(k) clearance on 2001-02-21, under 510(k) number K991259.

Who is the listed applicant for TE ME NA EPIDURAL CATHETER?

The FDA 510(k) record lists Te ME NA S.A.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TE ME NA EPIDURAL CATHETER?

The FDA product code for TE ME NA EPIDURAL CATHETER is BSO.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Te ME NA S.A.R.L. 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.

K990323TE ME NA POLYSTIM NERVE STIMILATORK002405SPINAL EPIDURAL NEEDLESK990100POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLEK990020TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC

Related Devices (Code: BSO)

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.

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 MedicalK193664SubQKath Catheter and Needle SetHk SurgicalK200624Percutaneous IntroducerEpimed International, Inc.K191470C-CAT Anaesthesia Catheter kitCimpax Aps

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.

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