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FDA 510(k)

DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM)

K-Number: K890432 · 1989-04-13

ApplicantDeknatel, Inc.
Decision Date1989-04-13
Product CodeDWS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Deknatel, Inc.. It received FDA 510(k) clearance on 1989-04-13 under 510(k) number K890432. 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 HIGH PRECISION VASCULAR PUNCH(TM)?

DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM) is a medical device that received FDA 510(k) clearance on 1989-04-13. The listed applicant is Deknatel, Inc.. The 510(k) number is K890432.

When did DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM) receive FDA 510(k) clearance?

DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM) received FDA 510(k) clearance on 1989-04-13, under 510(k) number K890432.

Who is the listed applicant for DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM)?

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

What is the FDA product code for DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM)?

The FDA product code for DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM) is DWS.

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Other records listing Deknatel, 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.

K963850PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEMK962683SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATORK964070DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAGK963098PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100)K962856PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTRK925243DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER

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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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