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FDA 510(k)

FLO-RESTER(R) VESSEL SIZER

K-Number: K905159 · 1991-02-07

ApplicantBio-Vascular, Inc.
Decision Date1991-02-07
Product CodeDWP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLO-RESTER(R) VESSEL SIZER is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Vascular, Inc.. It received FDA 510(k) clearance on 1991-02-07 under 510(k) number K905159. 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 FLO-RESTER(R) VESSEL SIZER?

FLO-RESTER(R) VESSEL SIZER is a medical device that received FDA 510(k) clearance on 1991-02-07. The listed applicant is Bio-Vascular, Inc.. The 510(k) number is K905159.

When did FLO-RESTER(R) VESSEL SIZER receive FDA 510(k) clearance?

FLO-RESTER(R) VESSEL SIZER received FDA 510(k) clearance on 1991-02-07, under 510(k) number K905159.

Who is the listed applicant for FLO-RESTER(R) VESSEL SIZER?

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

What is the FDA product code for FLO-RESTER(R) VESSEL SIZER?

The FDA product code for FLO-RESTER(R) VESSEL SIZER is DWP.

Related Clinical Trials

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Other records listing Bio-Vascular, 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.

K002233BVI SLINGK992537PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATEDK983602CV PERI-GUARD AND VASCU-GUARDK983581OCU-GUARD AND OCU-GUARD SUPPLEK983162PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASCK981624FLO-THRU

View all 26 devices →

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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