Combined End-Multiple Lateral Holes Epidural Catheter (Cemlh Epidural Catheter)

FDA 510(k) K951927 · Csen , Ltd.

Substantially Equivalent

510(k) numberK951927

Submission

Device name
Combined End-Multiple Lateral Holes Epidural Catheter (Cemlh Epidural Catheter)
Applicant
Csen , Ltd.
Israel, IL
Received
April 24, 1995
Decision date
May 30, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
BSO – Catheter, Conduction, Anesthetic
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5120
Specialty
Anesthesiology

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K230603Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen…BSO · Traditional Teleflex Medical08/30/2023SE
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K200624Percutaneous IntroducerBSO · Traditional Epimed International, Inc.04/27/2020SE
K191470C-CAT Anaesthesia Catheter kitBSO · Traditional Cimpax Aps10/25/2019SE
K181782Medline Reinforced Epidural CatheterBSO · Traditional Medline Industries, Inc.03/04/2019SE
K173541EpinautBSO · Traditional Imedicom Co., Ltd.08/24/2018SE
K172777Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7BSO · Traditional PAJUNK GmbH Medizintechnologie05/03/2018SE
K171584B. Braun Tear-Away Introducer NeedleBSO · Traditional B.Braun Medical, Inc.12/22/2017SE

More from B.Braun Medical, Inc.

510(k)DeviceDecision
K951928Double-Hole Pencile-Point Spinal Needle (DHPP Spinal Needle)BSP · Traditional 05/30/1997SE
K935255Eldor NeedleBSP · Traditional 02/01/1995SE

Questions and answers

When was Combined End-Multiple Lateral Holes Epidural Catheter (Cemlh Epidural Catheter) cleared by the FDA?

Combined End-Multiple Lateral Holes Epidural Catheter (Cemlh Epidural Catheter) (K951927) received a 510(k) decision of Substantially Equivalent on May 30, 1997, 767 days after the submission was received.

What is the product code of K951927?

The FDA product code is BSO – Catheter, Conduction, Anesthetic, a Class II (moderate risk) device regulated under 21 CFR 868.5120.