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FDA 510(k)

D903 AVANT ADULT HOLLOW FIBER OXYGENATOR

K-Number: K980600 · 1998-08-12

ApplicantDideco S.P.A.
Decision Date1998-08-12
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

D903 AVANT ADULT HOLLOW FIBER OXYGENATOR is the device name listed in this FDA 510(k) record. The listed applicant is Dideco S.P.A.. It received FDA 510(k) clearance on 1998-08-12 under 510(k) number K980600. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the D903 AVANT ADULT HOLLOW FIBER OXYGENATOR?

D903 AVANT ADULT HOLLOW FIBER OXYGENATOR is a medical device that received FDA 510(k) clearance on 1998-08-12. The listed applicant is Dideco S.P.A.. The 510(k) number is K980600.

When did D903 AVANT ADULT HOLLOW FIBER OXYGENATOR receive FDA 510(k) clearance?

D903 AVANT ADULT HOLLOW FIBER OXYGENATOR received FDA 510(k) clearance on 1998-08-12, under 510(k) number K980600.

Who is the listed applicant for D903 AVANT ADULT HOLLOW FIBER OXYGENATOR?

The FDA 510(k) record lists Dideco S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for D903 AVANT ADULT HOLLOW FIBER OXYGENATOR?

The FDA product code for D903 AVANT ADULT HOLLOW FIBER OXYGENATOR is JOW.

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Other records listing Dideco S.P.A. 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.

K041061D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERSK033323D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATINGK033987D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERSK033714MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATINGK032040IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATORK031223SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR

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Related Devices (Code: JOW)

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.

K261807Sequential Circulator (SC-4004-DL, SC-4008-DL)Bio Compression Systems, Inc.K254217AerloomEvolym, LLCK253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile MedicalK253386DVT GarmentVistar Medical Supplies Co., Ltd.K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , 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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