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FDA 510(k)

CARDIOPULMONARY BYPASS TUBING

K-Number: K801401 · 1980-06-30

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

Device Summary

CARDIOPULMONARY BYPASS 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 K801401. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOPULMONARY BYPASS TUBING?

CARDIOPULMONARY BYPASS 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 K801401.

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

CARDIOPULMONARY BYPASS TUBING received FDA 510(k) clearance on 1980-06-30, under 510(k) number K801401.

Who is the listed applicant for CARDIOPULMONARY BYPASS 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 TUBING?

The FDA product code for CARDIOPULMONARY BYPASS TUBING is DWF.

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Related Devices (Code: DWF)

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.

K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.K250937Venous Return CannulaeLivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart ReactorsK253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L.K253998Clearview Intracoronary ShuntsMedtronic, Inc.

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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