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FDA 510(k)

LEMAITRE RETROGRADE VALVULOTOME-MANU-SURGICA INSTR

K-Number: K850394 · 1985-04-24

ApplicantVascutech, Inc.
Decision Date1985-04-24
Product CodeDWS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LEMAITRE RETROGRADE VALVULOTOME-MANU-SURGICA INSTR is the device name listed in this FDA 510(k) record. The listed applicant is Vascutech, Inc.. It received FDA 510(k) clearance on 1985-04-24 under 510(k) number K850394. 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 LEMAITRE RETROGRADE VALVULOTOME-MANU-SURGICA INSTR?

LEMAITRE RETROGRADE VALVULOTOME-MANU-SURGICA INSTR is a medical device that received FDA 510(k) clearance on 1985-04-24. The listed applicant is Vascutech, Inc.. The 510(k) number is K850394.

When did LEMAITRE RETROGRADE VALVULOTOME-MANU-SURGICA INSTR receive FDA 510(k) clearance?

LEMAITRE RETROGRADE VALVULOTOME-MANU-SURGICA INSTR received FDA 510(k) clearance on 1985-04-24, under 510(k) number K850394.

Who is the listed applicant for LEMAITRE RETROGRADE VALVULOTOME-MANU-SURGICA INSTR?

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

What is the FDA product code for LEMAITRE RETROGRADE VALVULOTOME-MANU-SURGICA INSTR?

The FDA product code for LEMAITRE RETROGRADE VALVULOTOME-MANU-SURGICA INSTR is DWS.

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Other records listing Vascutech, Inc. as applicant

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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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