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FDA 510(k)

AORTIC ROOT CANNULA W/INTEGRAL PRESS

K-Number: K831591 · 1983-06-30

ApplicantDlp, Inc.
Decision Date1983-06-30
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AORTIC ROOT CANNULA W/INTEGRAL PRESS is the device name listed in this FDA 510(k) record. The listed applicant is Dlp, Inc.. It received FDA 510(k) clearance on 1983-06-30 under 510(k) number K831591. 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 AORTIC ROOT CANNULA W/INTEGRAL PRESS?

AORTIC ROOT CANNULA W/INTEGRAL PRESS is a medical device that received FDA 510(k) clearance on 1983-06-30. The listed applicant is Dlp, Inc.. The 510(k) number is K831591.

When did AORTIC ROOT CANNULA W/INTEGRAL PRESS receive FDA 510(k) clearance?

AORTIC ROOT CANNULA W/INTEGRAL PRESS received FDA 510(k) clearance on 1983-06-30, under 510(k) number K831591.

Who is the listed applicant for AORTIC ROOT CANNULA W/INTEGRAL PRESS?

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 AORTIC ROOT CANNULA W/INTEGRAL PRESS?

The FDA product code for AORTIC ROOT CANNULA W/INTEGRAL PRESS is DWF.

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Other records listing Dlp, Inc. as applicant

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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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