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FDA 510(k)

CARDIOPULMONARY BYPASS PUMP TUBING

K-Number: K910021 · 1991-05-22

ApplicantJtl Medical Corp.
Decision Date1991-05-22
Product CodeDWF
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 Jtl Medical Corp.. It received FDA 510(k) clearance on 1991-05-22 under 510(k) number K910021. 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 PUMP TUBING?

CARDIOPULMONARY BYPASS PUMP TUBING is a medical device that received FDA 510(k) clearance on 1991-05-22. The listed applicant is Jtl Medical Corp.. The 510(k) number is K910021.

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

CARDIOPULMONARY BYPASS PUMP TUBING received FDA 510(k) clearance on 1991-05-22, under 510(k) number K910021.

Who is the listed applicant for CARDIOPULMONARY BYPASS PUMP TUBING?

The FDA 510(k) record lists Jtl Medical Corp. 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 DWF.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Jtl Medical Corp. 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.

K910599CARDIOPULMONARY BYPASS LEVEL SENSING MONITORK905818VACUUM-ASSISTED BLOOD COLLECTION SYSTEM

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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