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FDA 510(k)

SUBMISSION CORONARY CANNULA

K-Number: K821149 · 1982-05-18

ApplicantDlp, Inc.
Decision Date1982-05-18
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SUBMISSION CORONARY CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Dlp, Inc.. It received FDA 510(k) clearance on 1982-05-18 under 510(k) number K821149. 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 SUBMISSION CORONARY CANNULA?

SUBMISSION CORONARY CANNULA is a medical device that received FDA 510(k) clearance on 1982-05-18. The listed applicant is Dlp, Inc.. The 510(k) number is K821149.

When did SUBMISSION CORONARY CANNULA receive FDA 510(k) clearance?

SUBMISSION CORONARY CANNULA received FDA 510(k) clearance on 1982-05-18, under 510(k) number K821149.

Who is the listed applicant for SUBMISSION CORONARY CANNULA?

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

What is the FDA product code for SUBMISSION CORONARY CANNULA?

The FDA product code for SUBMISSION CORONARY CANNULA is DWF.

Related Clinical Trials

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Other records listing Dlp, 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.

K973485CLEARVIEW BLOWER/MISTERK964445OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)K953945RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLETK950754MACRO SUCTION TUBE MODEL NO 10061K934215CONTAIN-ORK915268CATHETER TWO STAGE VENOUS RETURN

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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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