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FDA 510(k)

TRIPLE LUMEN INFUSION CATHETERIZATION SET OR KIT

K-Number: K870412 · 1987-05-27

ApplicantMedical Surgical Concepts, Inc.
Decision Date1987-05-27
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRIPLE LUMEN INFUSION CATHETERIZATION SET OR KIT is the device name listed in this FDA 510(k) record. The listed applicant is Medical Surgical Concepts, Inc.. It received FDA 510(k) clearance on 1987-05-27 under 510(k) number K870412. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIPLE LUMEN INFUSION CATHETERIZATION SET OR KIT?

TRIPLE LUMEN INFUSION CATHETERIZATION SET OR KIT is a medical device that received FDA 510(k) clearance on 1987-05-27. The listed applicant is Medical Surgical Concepts, Inc.. The 510(k) number is K870412.

When did TRIPLE LUMEN INFUSION CATHETERIZATION SET OR KIT receive FDA 510(k) clearance?

TRIPLE LUMEN INFUSION CATHETERIZATION SET OR KIT received FDA 510(k) clearance on 1987-05-27, under 510(k) number K870412.

Who is the listed applicant for TRIPLE LUMEN INFUSION CATHETERIZATION SET OR KIT?

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

What is the FDA product code for TRIPLE LUMEN INFUSION CATHETERIZATION SET OR KIT?

The FDA product code for TRIPLE LUMEN INFUSION CATHETERIZATION SET OR KIT is DQY.

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 Medical Surgical Concepts, 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.

K870411CENTRAL VEIN CATHERIZATION KIT W/WITHOUT MEDICA.K870413PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR)

Related Devices (Code: DQY)

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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

Official Source

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