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FDA 510(k)

EXTRACORPOREAL SUBCLAVIAN CATHETER KIT

K-Number: K823752 · 1983-01-14

ApplicantExtracorporeal Medical Specialities, Inc.
Decision Date1983-01-14
Product CodeFIQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EXTRACORPOREAL SUBCLAVIAN CATHETER KIT is the device name listed in this FDA 510(k) record. The listed applicant is Extracorporeal Medical Specialities, Inc.. It received FDA 510(k) clearance on 1983-01-14 under 510(k) number K823752. The device is classified under product code FIQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTRACORPOREAL SUBCLAVIAN CATHETER KIT?

EXTRACORPOREAL SUBCLAVIAN CATHETER KIT is a medical device that received FDA 510(k) clearance on 1983-01-14. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K823752.

When did EXTRACORPOREAL SUBCLAVIAN CATHETER KIT receive FDA 510(k) clearance?

EXTRACORPOREAL SUBCLAVIAN CATHETER KIT received FDA 510(k) clearance on 1983-01-14, under 510(k) number K823752.

Who is the listed applicant for EXTRACORPOREAL SUBCLAVIAN CATHETER KIT?

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

What is the FDA product code for EXTRACORPOREAL SUBCLAVIAN CATHETER KIT?

The FDA product code for EXTRACORPOREAL SUBCLAVIAN CATHETER KIT is FIQ.

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Other records listing Extracorporeal Medical Specialities, 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.

K843955EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATORK840262HANCOCK PERICARDIAL PATCHK840532HEMOPERFUSION SYSTEM TP-400K840057EXP* 500 PARALLEL PLATE DIALYZERK840146EXP* 700 PARALLEL PLATE DIALYZERK832547ULTRAFILTRATION CONTROLLER

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Related Devices (Code: FIQ)

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.

K892887ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULAAkcess Medical Products, Inc.K892663S-100 ALLEN-BROWN SHUNTAkcess Medical Products, Inc.K892666SAF-T-SHUNT, S-300 SERIESAkcess Medical Products, Inc.K844692PEDIATRIC SIZED HEMOCATH CATHETERQuinton, Inc.K841791PLUME FISTULA NEEDLEHospal Medical Corp.K840322HEMOFILTRATION CATHETER HF-100Vas-Cath of Canada , Ltd.

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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