FDA.reportPublic FDA data

Embotrap

Primary DI
10886704081319
Brand
Embotrap
Company
NEURAVI LIMITED
Model
ET009521
Catalog number
ET009521
Device description
EMBOTRAP II 5X21 REVASCULARISATION DEVICE
Published
2018-05-24
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
NRYCatheter, Thrombus Retriever

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRYCatheter, Thrombus RetrieverCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173452000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173452000EmboTrap ll Revascularization DeviceNeuravi, Ltd.2018-05-09NRY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886704081319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670408131910886704081319

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy suction catheterA flexible or semi-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. This is a single-use device.

Regulatory Flags#

DUNS number
985010416
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
10886704082866EMBOTRAPET309522ET3095222020-07-16
10886704081326EmbotrapET009533ET0095332018-05-24
10886704082736EMBOGUARDBG8785UBG8785U2021-12-22
10886704082743EMBOGUARDBG8795UBG8795U2021-12-22
10886704082859EMBOTRAPET309645ET3096452021-08-05
10886704084570EMBOTRAPET309537ET3095372020-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391539370296Millipede88 CatheterPERFUZE LIMITEDNRY2026-08-21
00857545008295Lynx Aspiration Catheter SystemQ'APEL MEDICAL LLCNRY2026-05-29
00857545008301Lynx Aspiration Catheter SystemQ'APEL MEDICAL LLCNRY2026-05-29
00857545008318Lynx Aspiration Catheter SystemQ'APEL MEDICAL LLCNRY2026-05-29
00857545008325Lynx Aspiration Catheter SystemQ'APEL MEDICAL LLCNRY2026-05-29
00857545008332Lynx Aspiration Catheter SystemQ'APEL MEDICAL LLCNRY2026-05-29
00763000974077Riptide™Micro Therapeutics, Inc.NRY2026-03-30
00850083646004NeVasc .070 Aspiration Catheter, 115 cmVesalioNRY2026-03-26
00851279008972NeVasc .070 Aspiration Catheter, 140 cmVesalioNRY2026-03-26
00851279008989NeVasc .070 Aspiration Catheter, 132 cmVesalioNRY2026-03-26
00851279008996NeVasc .070 Aspiration Catheter, 125 cmVesalioNRY2026-03-26
00850014025182APRO 45 Swift CatheterAlembic, LLCNRY2026-03-25
00850014025199APRO 45 Swift CatheterAlembic, LLCNRY2026-03-25
00850014025205APRO 45 Swift CatheterAlembic, LLCNRY2026-03-25
00850014025212APRO 45 Swift CatheterAlembic, LLCNRY2026-03-25
07290015107341Tigertriever 25 Revascularization DeviceRAPID MEDICAL LTDNRY2026-03-16
00763000950750Riptide™ Aspiration PumpMicro Therapeutics, Inc.NRY2026-03-09
05391530910231Esperance pHLO Aspiration SystemPHENOX LIMITEDNRY2026-02-10
05391530910248Esperance pHLO Aspiration SystemPHENOX LIMITEDNRY2026-02-10
00763000974091Riptide™Micro Therapeutics, Inc.NRY2025-12-13
00812212030764Zoom 4S CatheterIMPERATIVE CARE, INC.NRY2025-11-24
00812212030771Zoom 4S CatheterIMPERATIVE CARE, INC.NRY2025-11-24
00812212030788Zoom 4S CatheterIMPERATIVE CARE, INC.NRY2025-11-24
07290015107402Tigertriever 17 Ultra Revascularization DeviceRAPID MEDICAL LTDNRY2025-11-17
10886704088097CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704088103CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704088110CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704088141CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704086437CEREGLIDECerenovus, Inc.NRY2025-09-26
10886704086451CEREGLIDECerenovus, Inc.NRY2025-09-26