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FDA 510(k)

MODEL DM 353 & DM-353-L SINGLE NEEDLE

K-Number: K792174 · 1979-11-16

ApplicantExtracorporeal Medical Specialities, Inc.
Decision Date1979-11-16
Product CodeFIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODEL DM 353 & DM-353-L SINGLE NEEDLE 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 1979-11-16 under 510(k) number K792174. The device is classified under product code FIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL DM 353 & DM-353-L SINGLE NEEDLE?

MODEL DM 353 & DM-353-L SINGLE NEEDLE is a medical device that received FDA 510(k) clearance on 1979-11-16. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K792174.

When did MODEL DM 353 & DM-353-L SINGLE NEEDLE receive FDA 510(k) clearance?

MODEL DM 353 & DM-353-L SINGLE NEEDLE received FDA 510(k) clearance on 1979-11-16, under 510(k) number K792174.

Who is the listed applicant for MODEL DM 353 & DM-353-L SINGLE NEEDLE?

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 MODEL DM 353 & DM-353-L SINGLE NEEDLE?

The FDA product code for MODEL DM 353 & DM-353-L SINGLE NEEDLE is FIF.

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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: FIF)

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.

K8732798810 PUMP-PUMP SINGLE NEEDLE DEVICECd Medical, Inc.K820173COBE SINGLE-NEEDLE CONTROLLER #18-756Cobe Laboratories, Inc.K802230BELLCO SINGLE NEEDLE DOUBLE HEAD PUMPCardio Med Supplies, Inc.K801967MEDCOMP FEMORAL VEIN CATHETERMedical Components, Inc.K772147GW 35 GUIDE WIRESorensen Research

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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