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FDA 510(k)

EXTRACORP.'S INTERSEPT CUS. TUBING PK.

K-Number: K800178 · 1980-02-21

ApplicantExtracorporeal Medical Specialities, Inc.
Decision Date1980-02-21
Product CodeDWE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXTRACORP.'S INTERSEPT CUS. TUBING PK. 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 1980-02-21 under 510(k) number K800178. The device is classified under product code DWE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTRACORP.'S INTERSEPT CUS. TUBING PK.?

EXTRACORP.'S INTERSEPT CUS. TUBING PK. is a medical device that received FDA 510(k) clearance on 1980-02-21. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K800178.

When did EXTRACORP.'S INTERSEPT CUS. TUBING PK. receive FDA 510(k) clearance?

EXTRACORP.'S INTERSEPT CUS. TUBING PK. received FDA 510(k) clearance on 1980-02-21, under 510(k) number K800178.

Who is the listed applicant for EXTRACORP.'S INTERSEPT CUS. TUBING PK.?

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 EXTRACORP.'S INTERSEPT CUS. TUBING PK.?

The FDA product code for EXTRACORP.'S INTERSEPT CUS. TUBING PK. is DWE.

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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: DWE)

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.

K233702SMARxT Tubing and ConnectorsLivaNova USA, Inc.K092486VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUITVortex Medical, Inc.K080592HLM TUBING SET WITH BIOLINE COATINGMaquet Cardiopulmonary, AGK053025JOSTRA HLM TUBING SETMaquet Cardiopulmonary, AGK022857PUMP TUBING WITH X-COATINGTerumo Cardiovascular Systems CorporationK013578PUMP TUBINGTerumo Cardiovascular Systems Corp.

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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