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FDA 510(k)

HEART CATHETERIZATION TRAY

K-Number: K860161 · 1986-05-02

ApplicantMedical Design Concepts, Inc.
Decision Date1986-05-02
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEART CATHETERIZATION TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Medical Design Concepts, Inc.. It received FDA 510(k) clearance on 1986-05-02 under 510(k) number K860161. 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?

HEART CATHETERIZATION TRAY is a medical device that received FDA 510(k) clearance on 1986-05-02. The listed applicant is Medical Design Concepts, Inc.. The 510(k) number is K860161.

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

HEART CATHETERIZATION TRAY received FDA 510(k) clearance on 1986-05-02, under 510(k) number K860161.

Who is the listed applicant for HEART CATHETERIZATION TRAY?

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

What is the FDA product code for HEART CATHETERIZATION TRAY?

The FDA product code for HEART CATHETERIZATION TRAY is DRE.

Related Clinical Trials

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.

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Other records listing Medical Design Concepts, 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.

K860160OPERATING ROOM TRAY

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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