FDA.reportPublic FDA data

VortX™ - 18

Primary DI
08714729158882
Brand
VortX™ - 18
Company
BOSTON SCIENTIFIC CORPORATION
Model
M0013812040
Catalog number
M0013812040
Device description
Fibered Platinum Coil
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KRDDevice, Vascular, for Promoting Embolization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729158882PackageGS15In Commercial Distribution
08714729324850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729158882087147291588828714729158882
08714729324850087147293248508714729324850

GMDN Terms#

Term, Definition table
TermDefinition
Non-neurovascular embolization coilA non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an aneurysm or the vasculature surrounding a malformation; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000936594Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936600Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936617Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936624Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936631Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936648Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936655Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936662Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936679Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936686Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936693Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936709Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936716Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936723Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936730Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936747Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936754Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936761Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936778Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936785Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936792Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936808Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936815Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936822Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936839Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936846Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936853Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936860Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936877Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936884Concerto Versa™MEDTRONIC, INC.KRD2026-02-27