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FDA 510(k)

MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE TRAY

K-Number: K864461 · 1986-11-24

ApplicantMedsurg Industries, Inc.
Decision Date1986-11-24
Product CodeDWS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Medsurg Industries, Inc.. It received FDA 510(k) clearance on 1986-11-24 under 510(k) number K864461. The device is classified under product code DWS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE TRAY?

MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE TRAY is a medical device that received FDA 510(k) clearance on 1986-11-24. The listed applicant is Medsurg Industries, Inc.. The 510(k) number is K864461.

When did MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE TRAY receive FDA 510(k) clearance?

MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE TRAY received FDA 510(k) clearance on 1986-11-24, under 510(k) number K864461.

Who is the listed applicant for MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE TRAY?

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

What is the FDA product code for MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE TRAY?

The FDA product code for MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE TRAY is DWS.

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Other records listing Medsurg Industries, 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.

K920780MEDSURG INSERTION TRAYK940175MEDSURG STERILE O.R. TOWELSK934731MEDSURG STERILE IMAGING PRODUCTSK925558INFILTUBEK934971STERILE LAPAROTOMY SPONGESK920421MEDSURG MARSHMALLOW TRAY

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Related Devices (Code: DWS)

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.

K022238MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626Medtronic VascularK964445OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)Dlp, Inc.K962771BURKE CONGENITAL THORACOSCOPY INSTRUMENTSPilling Weck, Inc.K955689RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAYContour Fabricators of Florida, Inc.K960139G.E. STERILE ANGIOGRAPHIC TRAYGE Medical SystemsK960144G.E. STERILE CT BIOPSY TRAYGE Medical Systems

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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