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FDA 510(k)

HEART CATHETERIZATION TRAY SET

K-Number: K840022 · 1984-02-04

ApplicantMedi-Plast Intl., Inc.
Decision Date1984-02-04
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEART CATHETERIZATION TRAY SET is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Plast Intl., Inc.. It received FDA 510(k) clearance on 1984-02-04 under 510(k) number K840022. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEART CATHETERIZATION TRAY SET?

HEART CATHETERIZATION TRAY SET is a medical device that received FDA 510(k) clearance on 1984-02-04. The listed applicant is Medi-Plast Intl., Inc.. The 510(k) number is K840022.

When did HEART CATHETERIZATION TRAY SET receive FDA 510(k) clearance?

HEART CATHETERIZATION TRAY SET received FDA 510(k) clearance on 1984-02-04, under 510(k) number K840022.

Who is the listed applicant for HEART CATHETERIZATION TRAY SET?

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

What is the FDA product code for HEART CATHETERIZATION TRAY SET?

The FDA product code for HEART CATHETERIZATION TRAY SET is DRE.

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Other records listing Medi-Plast Intl., 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.

K954284MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON)K87358810CC CONTROL SYRINGEK863402MEDI-PLAST DISPOSABLE MANIFOLDK861785FLUOROSCOPE BAND BAGK851489ARTERIAL-VENOUS COMPRESSION DRESSINGK842136STERILE PAN SET

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Related Devices (Code: DRE)

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.

K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc.K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L.K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K242229Micro Ace Gold Advanced Micro Access SystemMerit Medical Systems, Inc.K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, 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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