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FDA 510(k)

PORTEX EPIDURAL CATHETER

K-Number: K062005 · 2006-10-18

ApplicantSmiths Medical Asd, Inc.
Decision Date2006-10-18
Product CodeBSO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PORTEX EPIDURAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2006-10-18 under 510(k) number K062005. 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 PORTEX EPIDURAL CATHETER?

PORTEX EPIDURAL CATHETER is a medical device that received FDA 510(k) clearance on 2006-10-18. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K062005.

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

PORTEX EPIDURAL CATHETER received FDA 510(k) clearance on 2006-10-18, under 510(k) number K062005.

Who is the listed applicant for PORTEX EPIDURAL CATHETER?

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

What is the FDA product code for PORTEX EPIDURAL CATHETER?

The FDA product code for PORTEX EPIDURAL CATHETER is BSO.

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Other records listing Smiths Medical Asd, Inc. as applicant

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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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