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FDA 510(k)

CARDIOPULMONARY BYPASS PUMP TUBING

K-Number: K801394 · 1980-06-30

ApplicantTexas Medical Products, Inc.
Decision Date1980-06-30
Product CodeDWE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOPULMONARY BYPASS PUMP TUBING is the device name listed in this FDA 510(k) record. The listed applicant is Texas Medical Products, Inc.. It received FDA 510(k) clearance on 1980-06-30 under 510(k) number K801394. 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 CARDIOPULMONARY BYPASS PUMP TUBING?

CARDIOPULMONARY BYPASS PUMP TUBING is a medical device that received FDA 510(k) clearance on 1980-06-30. The listed applicant is Texas Medical Products, Inc.. The 510(k) number is K801394.

When did CARDIOPULMONARY BYPASS PUMP TUBING receive FDA 510(k) clearance?

CARDIOPULMONARY BYPASS PUMP TUBING received FDA 510(k) clearance on 1980-06-30, under 510(k) number K801394.

Who is the listed applicant for CARDIOPULMONARY BYPASS PUMP TUBING?

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

What is the FDA product code for CARDIOPULMONARY BYPASS PUMP TUBING?

The FDA product code for CARDIOPULMONARY BYPASS PUMP TUBING is DWE.

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Other records listing Texas Medical Products, Inc. as applicant

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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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