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FDA 510(k)

VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124

K-Number: K023140 · 2003-08-15

ApplicantEpimed International, Inc.
Decision Date2003-08-15
Product CodeBSO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124 is the device name listed in this FDA 510(k) record. The listed applicant is Epimed International, Inc.. It received FDA 510(k) clearance on 2003-08-15 under 510(k) number K023140. 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 VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124?

VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124 is a medical device that received FDA 510(k) clearance on 2003-08-15. The listed applicant is Epimed International, Inc.. The 510(k) number is K023140.

When did VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124 receive FDA 510(k) clearance?

VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124 received FDA 510(k) clearance on 2003-08-15, under 510(k) number K023140.

Who is the listed applicant for VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124?

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

What is the FDA product code for VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124?

The FDA product code for VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124 is BSO.

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Other records listing Epimed International, 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.

K200624Percutaneous IntroducerK190256Rulo Radiofrequency Lesion ProbeK053318RX EPIDURAL NEEDLEK051171STINGRAY EPIDURAL CATHETER CONNECTORK051860FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837K043467FLEXIBLE SPINAL NEEDLE

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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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