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FDA 510(k)

CONCORD/PORTEX EPIDURAL CATHETERS

K-Number: K935927 · 1994-09-09

ApplicantSmiths Industries Medical Systems, Inc.
Decision Date1994-09-09
Product CodeBSO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CONCORD/PORTEX EPIDURAL CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Industries Medical Systems, Inc.. It received FDA 510(k) clearance on 1994-09-09 under 510(k) number K935927. 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 CONCORD/PORTEX EPIDURAL CATHETERS?

CONCORD/PORTEX EPIDURAL CATHETERS is a medical device that received FDA 510(k) clearance on 1994-09-09. The listed applicant is Smiths Industries Medical Systems, Inc.. The 510(k) number is K935927.

When did CONCORD/PORTEX EPIDURAL CATHETERS receive FDA 510(k) clearance?

CONCORD/PORTEX EPIDURAL CATHETERS received FDA 510(k) clearance on 1994-09-09, under 510(k) number K935927.

Who is the listed applicant for CONCORD/PORTEX EPIDURAL CATHETERS?

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

What is the FDA product code for CONCORD/PORTEX EPIDURAL CATHETERS?

The FDA product code for CONCORD/PORTEX EPIDURAL CATHETERS is BSO.

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Other records listing Smiths Industries Medical Systems, 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.

K972385FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFEDK965017REGIONAL ANESTHESIA TRAYSK962175PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBEK962931SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KITK963570SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22)K960429PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA

View all 22 devices →

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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