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FDA 510(k)

CARDIOVASCULAR DISPOSABLE PRODUCTS

K-Number: K830728 · 1983-04-28

ApplicantElectromics, Inc.
Decision Date1983-04-28
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOVASCULAR DISPOSABLE PRODUCTS is the device name listed in this FDA 510(k) record. The listed applicant is Electromics, Inc.. It received FDA 510(k) clearance on 1983-04-28 under 510(k) number K830728. 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 CARDIOVASCULAR DISPOSABLE PRODUCTS?

CARDIOVASCULAR DISPOSABLE PRODUCTS is a medical device that received FDA 510(k) clearance on 1983-04-28. The listed applicant is Electromics, Inc.. The 510(k) number is K830728.

When did CARDIOVASCULAR DISPOSABLE PRODUCTS receive FDA 510(k) clearance?

CARDIOVASCULAR DISPOSABLE PRODUCTS received FDA 510(k) clearance on 1983-04-28, under 510(k) number K830728.

Who is the listed applicant for CARDIOVASCULAR DISPOSABLE PRODUCTS?

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

What is the FDA product code for CARDIOVASCULAR DISPOSABLE PRODUCTS?

The FDA product code for CARDIOVASCULAR DISPOSABLE PRODUCTS is DWF.

Related Clinical Trials

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Other records listing Electromics, 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.

K830727CARDIOTOMY RESERVOIR-FILTERED & NON

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

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