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FDA 510(k)

CAROTID BYPASS SHUNT WITH SAMPLING ARM

K-Number: K860743 · 1986-05-28

ApplicantClincal Instruments Corp.
Decision Date1986-05-28
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CAROTID BYPASS SHUNT WITH SAMPLING ARM is the device name listed in this FDA 510(k) record. The listed applicant is Clincal Instruments Corp.. It received FDA 510(k) clearance on 1986-05-28 under 510(k) number K860743. 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 CAROTID BYPASS SHUNT WITH SAMPLING ARM?

CAROTID BYPASS SHUNT WITH SAMPLING ARM is a medical device that received FDA 510(k) clearance on 1986-05-28. The listed applicant is Clincal Instruments Corp.. The 510(k) number is K860743.

When did CAROTID BYPASS SHUNT WITH SAMPLING ARM receive FDA 510(k) clearance?

CAROTID BYPASS SHUNT WITH SAMPLING ARM received FDA 510(k) clearance on 1986-05-28, under 510(k) number K860743.

Who is the listed applicant for CAROTID BYPASS SHUNT WITH SAMPLING ARM?

The FDA 510(k) record lists Clincal Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAROTID BYPASS SHUNT WITH SAMPLING ARM?

The FDA product code for CAROTID BYPASS SHUNT WITH SAMPLING ARM is DWF.

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Other records listing Clincal Instruments 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.

K902327EMBOLECTOMY CATHETERK860742CAROTID BYPASS SHUNTK852704TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIATK844918OCCLUSION & OCCLUSION-IRRIGATIONK821220MULTILUMEN INTRAVENOUS INFUSION CATHETERK790034INTRODUCERS

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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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