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FDA 510(k)

EXV VENOUS RESERVOIR BAG & HOLDER

K-Number: K823205 · 1982-11-24

ApplicantExtracorporeal Medical Specialities, Inc.
Decision Date1982-11-24
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXV VENOUS RESERVOIR BAG & HOLDER 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 1982-11-24 under 510(k) number K823205. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXV VENOUS RESERVOIR BAG & HOLDER?

EXV VENOUS RESERVOIR BAG & HOLDER is a medical device that received FDA 510(k) clearance on 1982-11-24. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K823205.

When did EXV VENOUS RESERVOIR BAG & HOLDER receive FDA 510(k) clearance?

EXV VENOUS RESERVOIR BAG & HOLDER received FDA 510(k) clearance on 1982-11-24, under 510(k) number K823205.

Who is the listed applicant for EXV VENOUS RESERVOIR BAG & HOLDER?

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 EXV VENOUS RESERVOIR BAG & HOLDER?

The FDA product code for EXV VENOUS RESERVOIR BAG & HOLDER is DTN.

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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: DTN)

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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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