FDA.reportPublic FDA data

Zoom 4S Catheter

Primary DI
00812212030764
Brand
Zoom 4S Catheter
Company
IMPERATIVE CARE, INC.
Model
ICRC04S160
Catalog number
ICRC04S160
Device description
Zoom 4S Catheter, 160cm
Published
2025-11-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NRYCatheter, Thrombus Retriever
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRYCatheter, Thrombus RetrieverCardiovascular2
QJPCatheter, Percutaneous, NeurovasculatureCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812212030764PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812212030764008122120307648122120307640812212030764

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Length0
Lumen/Inner Diameter0
Outer Diameter0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry. Keep away from sunlight. Store at room temperature.

Contacts#

Phone, Email table
PhoneEmail
1-408-502-7548CustomerService@Imperativecare.com

Regulatory Flags#

DUNS number
080816678
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812212030771Zoom 4S CatheterICRC04S144ICRC04S1442025-11-24
00812212030788Zoom 4S CatheterICRC04S125ICRC04S1252025-11-24
00812212030108TracStar™ Large Distal PlatformICAC088080ICAC0880802019-04-30
00812212030115TracStar™ Large Distal PlatformICAC088090ICAC0880902019-04-30
00812212030146ZOOM™ 88 Large Distal PlatformICFC088100ICFC0881002019-04-30
00812212030153ZOOM™ 88 Large Distal PlatformICFC088110ICFC0881102019-04-30
00812212030573Zoom 88 Large Distal Platform SupportICTC088100SICTC088100S2023-06-02
00812212030511Zoom RDL Radial Access System, 95cmICTC088095RICTC088095R2022-09-28
00812212030528Zoom RDL Radial Access System, 105cmICTC088105RICTC088105R2022-09-28
00812212030535Zoom RDL Radial Access System, 110cmICTC088110RICTC088110R2022-09-28
00812212030566Zoom RDL Radial Access System, 103cmICTC088103RICTC088103R2022-09-28
00812212030399TracStar™ Large Distal PlatformICAC088095ICAC0880952022-08-11
00812212030405ZOOM™ 88 Large Distal PlatformICTC088110ICTC0881102022-08-11
00812212030467TracStar™ Large Distal PlatformICAC088105ICAC0881052022-08-11
00812212030337TracStar LDP Large Distal PlatformICAC088095ICAC0880952021-09-22
00812212030344TracStar LDP Large Distal PlatformICAC088105ICAC0881052021-09-22
00812212030351ZOOM™ 88 Large Distal PlatformICTC088100ICTC0881002021-09-22
00812212030368Zoom 88 Large Distal PlatformICTC088110ICTC0881102021-09-22
00812212030504ZOOM™ 88-T Large Distal PlatformICTC088110ICTC0881102021-09-22
00812212030160ZOOM™ 88-T Large Distal PlatformICTC088100ICTC0881002020-03-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391539370296Millipede88 CatheterPERFUZE LIMITEDNRY2026-08-21
0086001552775287 NeuGlide CatheterPIRAEUS MEDICAL INC.QJP2026-08-06
0086001552776987 NeuGlide CatheterPIRAEUS MEDICAL INC.QJP2026-08-06
00850074235132Toro 88 Superbore CatheterToro Neurovascular, Inc.QJP2026-07-31
05391539370173Millipede88 Access CatheterPERFUZE LIMITEDQJP2026-07-15
008537990079308F Base Camp System 2.0 90cmROUTE 92 MEDICALQJP2026-07-08
04547327166140SAYA 86ASAHI INTECC CO., LTD.QJP2026-06-12
04547327166157SAYA 86ASAHI INTECC CO., LTD.QJP2026-06-12
04547327166164SAYA 86ASAHI INTECC CO., LTD.QJP2026-06-12
04547327166171SAYA 86ASAHI INTECC CO., LTD.QJP2026-06-12
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04547327166195SAYA 86ASAHI INTECC CO., LTD.QJP2026-06-12
04547327166201SAYA 86ASAHI INTECC CO., LTD.QJP2026-06-12
04547327166218SAYA 86ASAHI INTECC CO., LTD.QJP2026-06-12
04547327166225SAYA 86ASAHI INTECC CO., LTD.QJP2026-06-12
04547327166232SAYA 86ASAHI INTECC CO., LTD.QJP2026-06-12
04547327166249SAYA 86ASAHI INTECC CO., LTD.QJP2026-06-12
04547327166256SAYA 86ASAHI INTECC CO., LTD.QJP2026-06-12
0086001552770787 NeuGlide+ CatheterPIRAEUS MEDICAL INC.QJP2026-05-18
0086001552771487 NeuGlide+ CatheterPIRAEUS MEDICAL INC.QJP2026-05-18
00850014025397APRO 45 Intermediate CatheterAlembic, LLCQJP2026-03-25
00850014025403APRO 45 Intermediate CatheterAlembic, LLCQJP2026-03-25
00850014025410APRO 45 Intermediate CatheterAlembic, LLCQJP2026-03-25
00850014025427APRO 45 Intermediate CatheterAlembic, LLCQJP2026-03-25
05391539370197Millipede 088 Access CatheterPERFUZE LIMITEDQJP2026-03-24
00850074235101Toro 88 Superbore CatheterToro Neurovascular, Inc.QJP2026-02-16
0086001030636987 NeuGlide+ CatheterPIRAEUS MEDICAL INC.QJP2026-02-02
0086001030637687 NeuGlide+ CatheterPIRAEUS MEDICAL INC.QJP2026-02-02
00860013060619Toro 88 Superbore CatheterToro Neurovascular, Inc.QJP2026-02-02
00812212030771Zoom 4S CatheterIMPERATIVE CARE, INC.QJP2025-11-24