FDA.reportPublic FDA data

AngioJet™ Solent™ Dista

Primary DI
08714729889731
Brand
AngioJet™ Solent™ Dista
Company
BOSTON SCIENTIFIC CORPORATION
Model
111303-001
Device description
Thrombectomy Set
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
DXECATHETER, EMBOLECTOMY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXECatheter, EmbolectomyCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729889731PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729889731087147298897318714729889731

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy suction catheterA flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter to obtain blood samples. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
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
20841156110519PRONTOTELEFLEX INCORPORATEDDXE2026-03-03
00850291007697Large Bore 60 cc SyringeINARI MEDICAL INCDXE2024-12-20
00763000762360Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762377Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762384Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762391Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
08886483507524Embolectomy CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.DXE2023-10-31
00860010378007ICHORICHOR VASCULAR, INC.DXE2023-10-13
20801902196600ARROWTELEFLEX INCORPORATEDDXE2022-11-15
20801902194040ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194057ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194064ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194071ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194088ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194095ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194101ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902196617ARROWTELEFLEX INCORPORATEDDXE2022-11-08
00815948023802Indigo SystemPENUMBRA, INC.DXE2022-09-01
00815948023857Indigo SystemPENUMBRA, INC.DXE2022-09-01
00815948024281IndigoPENUMBRA, INC.DXE2022-03-04
00815948024335Indigo SystemPENUMBRA, INC.DXE2022-03-04
00815948024342Indigo SystemPENUMBRA, INC.DXE2022-03-04
00840663109616Syntel Silicone Embolectomy CatheterLemaitre Vascular, Inc.DXE2021-06-18
00840663109623Syntel Silicone Embolectomy CatheterLemaitre Vascular, Inc.DXE2021-06-18
00840663109630Syntel Silicone Embolectomy CatheterLemaitre Vascular, Inc.DXE2021-06-18
00840663109647Syntel Silicone Embolectomy CatheterLemaitre Vascular, Inc.DXE2021-06-18
00840663109654Syntel Silicone Embolectomy CatheterLemaitre Vascular, Inc.DXE2021-06-18
00840663109661Syntel Silicone Embolectomy CatheterLemaitre Vascular, Inc.DXE2021-06-18
00840663109678Syntel Silicone Embolectomy CatheterLemaitre Vascular, Inc.DXE2021-06-18
00840663109685Syntel Silicone Embolectomy CatheterLemaitre Vascular, Inc.DXE2021-06-18