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FDA 510(k)

DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH

K-Number: K820258 · 1982-03-02

ApplicantHowmedica Corp.
Decision Date1982-03-02
Product CodeDWS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1982-03-02 under 510(k) number K820258. 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 DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH?

DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH is a medical device that received FDA 510(k) clearance on 1982-03-02. The listed applicant is Howmedica Corp.. The 510(k) number is K820258.

When did DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH receive FDA 510(k) clearance?

DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH received FDA 510(k) clearance on 1982-03-02, under 510(k) number K820258.

Who is the listed applicant for DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH?

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

What is the FDA product code for DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH?

The FDA product code for DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH is DWS.

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Other records listing Howmedica Corp. as applicant

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K983528MICRO DYNAMIC MESHK983404TYPE 3 FEMORAL COMPONENTSK980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATIONK980925DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATIONK980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATIONK980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

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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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