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510(k) K942812

Device
FLO-RESTER DISPOSABLE VESSEL OCCLUDER
Applicant
BIO-VASCULAR, INC.
510(k) number
K942812
Product code
DXC  
Decision
Substantially Equivalent (SESE)
Decision date
1994-08-01
Date received
1994-06-14
Regulation
870.4450
Classification name
Clamp, Vascular
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
BRUCE A MACFARLANE, PH.D.
Address
2670 Patton Rd. St. Paul MN US 55113 55113

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DXC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc.2026-07-22
K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsEdwards Lifesciences2026-06-05
K252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc.2026-05-22
K254060Life Saving TourniquetTW Medical2026-04-03
K243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)Arc Trauma, LLC2025-12-31
K253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)Medline Industries, LP2025-11-20
K232577Radial Compression DeviceNingbo Dizegens Medical Science Co.,Ltd2024-01-18
K230281PICOCLAMPKono Seisakusho Co., Ltd.2023-10-23
K221661Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)Compression Works, Inc.2023-03-03
K230248VIOLAVascular Graft Solutions, Ltd.2023-02-28
K222182Radial Artery Compression TourniquetsBeijing Demax Medical Technology Co.,Ltd2023-01-04
K221843GEM Biover Microvascular ClampsSynovis Micro Companies Alliance, Inc.2022-09-14
K213531TR BAND Radial Compression DeviceTerumo Medical Corporation2021-12-20
K210681SiteSeal SVEnsite Vascular2021-04-06
K210006MI DeTACHBiorep Technologies, Inc.2021-03-04

Legacy Summary#

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FDA Review#

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