FDA.reportPublic FDA data

AVVIGO™+

Primary DI
00191506033149
Brand
AVVIGO™+
Company
BOSTON SCIENTIFIC CORPORATION
Model
H7492493120D0
Catalog number
H7492493120D0
Device description
Multi-Modality Guidance System
Published
2023-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DQKComputer, diagnostic, programmable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191506033149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506033149001915060331491915060331490191506033149

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular ultrasound imaging systemAn assembly of mains electricity (AC-powered) devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) imaging procedures involving the heart and blood vessels. Included are software packages that support a variety of static or real-time cardiac specific imaging applications used to diagnose anatomical defects of the heart, determine blood flow characteristics and functional/anatomical problems associated with myocardial infarction. It is used to generate ultrasound pulses, direct them to a target area, detect the echoes, and process the resulting information to produce and display static or dynamic two or three-dimensional (3-D) images.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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17540262170047Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2026-03-09
06944413849570Holter ECG and ABP SystemEdan Instruments, Inc.DQK2026-03-02
00195278343383CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DQK2026-02-11
00195278343512CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DQK2026-02-11
00851424007089VIVOCatheter Precision, Inc.DQK2026-02-03
00085142400710VIVO Positioning PatchesCatheter Precision, Inc.DQK2026-02-03
00851424007119VIVO SystemCatheter Precision, Inc.DQK2026-02-03
05415067055613EnSite™ST. JUDE MEDICAL, INC.DQK2026-01-08
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05415067053435EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
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05415067051219EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-08
05415067051288EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-08
03770019196069Volta AF-Xplorer IISUBSTRATE HDDQK2025-11-18
00763000998394N/AMEDTRONIC, INC.DQK2025-11-14
05415067051158EnSite™ST. JUDE MEDICAL, INC.DQK2025-09-15
05415067051172EnSite™ST. JUDE MEDICAL, INC.DQK2025-09-15