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FDA 510(k)

BIO-MATE(TM) EPIDURAL CATHETER

K-Number: K884969 · 1989-06-23

ApplicantMedevice, Inc.
Decision Date1989-06-23
Product CodeBSO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BIO-MATE(TM) EPIDURAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Medevice, Inc.. It received FDA 510(k) clearance on 1989-06-23 under 510(k) number K884969. 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 BIO-MATE(TM) EPIDURAL CATHETER?

BIO-MATE(TM) EPIDURAL CATHETER is a medical device that received FDA 510(k) clearance on 1989-06-23. The listed applicant is Medevice, Inc.. The 510(k) number is K884969.

When did BIO-MATE(TM) EPIDURAL CATHETER receive FDA 510(k) clearance?

BIO-MATE(TM) EPIDURAL CATHETER received FDA 510(k) clearance on 1989-06-23, under 510(k) number K884969.

Who is the listed applicant for BIO-MATE(TM) EPIDURAL CATHETER?

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

What is the FDA product code for BIO-MATE(TM) EPIDURAL CATHETER?

The FDA product code for BIO-MATE(TM) 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 Medevice, 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.

K072550SIGHTSURE OPERATIONAL INDICATOR, MODEL SS301K920638BIO-MATE PIC CATHETERK912856MEDE-FLO I.V. EXTENSION SETK901129BIO-MATE(TM) PEDIATRIC EPIDURAL CATHETER

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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