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FDA 510(k)

CONTINUOUS EPIDURAL ANESTHESIA TRAY/DRUG

K-Number: K802065 · 1980-09-09

ApplicantPortex, Inc.
Decision Date1980-09-09
Product CodeBSO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CONTINUOUS EPIDURAL ANESTHESIA TRAY/DRUG is the device name listed in this FDA 510(k) record. The listed applicant is Portex, Inc.. It received FDA 510(k) clearance on 1980-09-09 under 510(k) number K802065. 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 CONTINUOUS EPIDURAL ANESTHESIA TRAY/DRUG?

CONTINUOUS EPIDURAL ANESTHESIA TRAY/DRUG is a medical device that received FDA 510(k) clearance on 1980-09-09. The listed applicant is Portex, Inc.. The 510(k) number is K802065.

When did CONTINUOUS EPIDURAL ANESTHESIA TRAY/DRUG receive FDA 510(k) clearance?

CONTINUOUS EPIDURAL ANESTHESIA TRAY/DRUG received FDA 510(k) clearance on 1980-09-09, under 510(k) number K802065.

Who is the listed applicant for CONTINUOUS EPIDURAL ANESTHESIA TRAY/DRUG?

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

What is the FDA product code for CONTINUOUS EPIDURAL ANESTHESIA TRAY/DRUG?

The FDA product code for CONTINUOUS EPIDURAL ANESTHESIA TRAY/DRUG is BSO.

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Other records listing Portex, 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.

K033080PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETERK031057PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KITK0237931ST RESPONSE INTERMEDIATE MANUAL RESUSCITATORK0141151ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XXK014073HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICEK873992LARYNGECTOMY TUBE

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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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