FDA.reportPublic FDA data

Equalizer™

Primary DI
08714729402381
Brand
Equalizer™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M001171080
Device description
Occlusion Balloon Catheter
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MJNCatheter, intravascular occluding, temporary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJNCatheter, Intravascular Occluding, TemporaryCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729402381PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729402381087147294023818714729402381

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular occluding balloon catheter, image-guidedA non-powered flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and intracranial vasculature occlusion, emergency control of haemorrhage, to treat aneurysms, chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design for balloon inflation, introduction over a guidewire, infusion of contrast medium, or delivery of a smaller catheter or embolic agents; some types have graduated markings to assist insertion. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506004583WATCHMAN FLX™ ProM635WU60200M635WU602002023-09-12
00191506004590WATCHMAN FLX™ ProM635WU60240M635WU602402023-09-12
00191506004606WATCHMAN FLX™ ProM635WU60270M635WU602702023-09-12
00191506004613WATCHMAN FLX™ ProM635WU60310M635WU603102023-09-12
00191506004620WATCHMAN FLX™ ProM635WU60350M635WU603502023-09-12
00191506004637WATCHMAN FLX™ ProM635WU60400M635WU604002023-09-12
08714729195573RotaWire™ and wireClip™ TorquerH802232390010H8022323900102014-09-24
08714729195566RotaWire™ and wireClip™ TorquerH802228240020H8022282400202014-09-24
08714729837527Stingray™H749M3004A02016-09-24
08714729877523EP XT™M0042007720M00420077202016-09-24
08714729877714Dynamic XT™M0042011120M00420111202016-09-24
08714729879947EP XT™M0046EPXT00390M0046EPXT003902016-09-24
08714729181088Percuflex™ BiliaryM005337602015-09-24
08714729181095Percuflex™ BiliaryM005337702015-09-24
08714729181101Percuflex™ BiliaryM005337802015-09-24
08714729181118Percuflex™ BiliaryM005337902015-09-24
08714729181125Percuflex™ BiliaryM005338002015-09-24
08714729181132Percuflex™ BiliaryM005338102015-09-24
08714729181149Percuflex™ BiliaryM005338202015-09-24
08714729181156Percuflex™ BiliaryM005338302015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842429117552SCEPTERMICROVENTION INC.MJN2025-04-30
00842429117569SCEPTERMICROVENTION INC.MJN2025-04-30
00842429106884Balloon CatheterMICROVENTION INC.MJN2025-04-22
00842429106891Balloon CatheterMICROVENTION INC.MJN2025-04-22
00842429106907Balloon CatheterMICROVENTION INC.MJN2025-04-22
10628678061054COBRA-OS®Front Line Medical Technologies Inc.MJN2024-03-22
10628678061061Syringe, 10 mLFront Line Medical Technologies Inc.MJN2024-03-22
B090LRN0591LANDMARKZIEN MEDICAL TECHNOLOGIES, INC.MJN2024-01-23
10628678061009COBRA-OS™Front Line Medical Technologies Inc.MJN2023-08-25
10628678061016COBRA-OS™Front Line Medical Technologies Inc.MJN2023-08-25
10628678061023Syringe, 10 mLFront Line Medical Technologies Inc.MJN2023-08-25
00842429103388Balloon CatheterMICROVENTION INC.MJN2022-06-14
00853359008414SniperEmbolx, Inc.MJN2022-05-18
16286780610016COBRA-OS™Front Line Medical Technologies Inc.MJN2022-02-09
16286780610023Syringe, 10 mLFront Line Medical Technologies Inc.MJN2022-02-09
16286780610009COBRA-OS™Front Line Medical Technologies Inc.MJN2022-01-28
00860005855100ArchCathArch Catheter LLCMJN2021-03-01
00860005855124ArchCathArch Catheter LLCMJN2021-03-01
04046955677269PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INCMJN2021-02-19
04046955677221PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INCMJN2021-02-13
04046955677245PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INCMJN2021-02-13
04046955677283PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INCMJN2021-02-13
04046955677306PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INCMJN2021-02-13
04046955677320PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INCMJN2021-02-13
04046955677344PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INCMJN2021-02-13
04046955677368PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INCMJN2021-02-13
04046955677382PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INCMJN2021-02-13
04046955677405PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INCMJN2021-02-13
00851994005003RenovoCathRenovorx, Inc.MJN2020-11-19
00763000294144HyperFormMicro Therapeutics, Inc.MJN2020-08-01