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FDA 510(k)

LEMAITRE-BOOKWALTER VESSEL DEVICES

K-Number: K912548 · 1991-09-18

ApplicantVascutech, Inc.
Decision Date1991-09-18
Product CodeDWP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LEMAITRE-BOOKWALTER VESSEL DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Vascutech, Inc.. It received FDA 510(k) clearance on 1991-09-18 under 510(k) number K912548. The device is classified under product code DWP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEMAITRE-BOOKWALTER VESSEL DEVICES?

LEMAITRE-BOOKWALTER VESSEL DEVICES is a medical device that received FDA 510(k) clearance on 1991-09-18. The listed applicant is Vascutech, Inc.. The 510(k) number is K912548.

When did LEMAITRE-BOOKWALTER VESSEL DEVICES receive FDA 510(k) clearance?

LEMAITRE-BOOKWALTER VESSEL DEVICES received FDA 510(k) clearance on 1991-09-18, under 510(k) number K912548.

Who is the listed applicant for LEMAITRE-BOOKWALTER VESSEL DEVICES?

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-BOOKWALTER VESSEL DEVICES?

The FDA product code for LEMAITRE-BOOKWALTER VESSEL DEVICES is DWP.

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Other records listing Vascutech, 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.

K001621DARDIK CAROTID SHUNTK992942LEMAITRE OCCLUSION CATHETERK992933LEMAITRE IRRIGATION CATHETERK992934LEMAITRE VENOUS THROMBECTOMY CATHETERK992940LEMAITRE BALLOON CATHETER WITH IRRIGATIONK992941LEMAITRE BILIARY CATHETER

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Related Devices (Code: DWP)

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.

K220981SUPERPLAST Double-Occluder, SUPERPLAST Vascular ProbeFehling Surgical Instruments, Inc.K183438Geomed Vascular DilatorsGeomed Medizin-Technik GmbH & Co.K163524Vessel DilatorFetzer Medical GmbH & Co. KGK130896VASCULAR PROBE, VASCULAR PROBE ESSynovis Life Technologies, Inc.K100518INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054Instrumed International, Inc.K030788KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORSGeister Medizin Technik GmbH

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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