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FDA 510(k)

RACZ EPIDURAL CATHETER

K-Number: K954584 · 1996-10-08

ApplicantMedic Evaluation Devices & Instruments Corp.
Decision Date1996-10-08
Product CodeBSO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RACZ EPIDURAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Medic Evaluation Devices & Instruments Corp.. It received FDA 510(k) clearance on 1996-10-08 under 510(k) number K954584. 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 RACZ EPIDURAL CATHETER?

RACZ EPIDURAL CATHETER is a medical device that received FDA 510(k) clearance on 1996-10-08. The listed applicant is Medic Evaluation Devices & Instruments Corp.. The 510(k) number is K954584.

When did RACZ EPIDURAL CATHETER receive FDA 510(k) clearance?

RACZ EPIDURAL CATHETER received FDA 510(k) clearance on 1996-10-08, under 510(k) number K954584.

Who is the listed applicant for RACZ EPIDURAL CATHETER?

The FDA 510(k) record lists Medic Evaluation Devices & Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RACZ EPIDURAL CATHETER?

The FDA product code for RACZ 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.

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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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