FDA.reportPublic FDA data

Symphony™ Clot Container

Primary DI
00850032079167
Brand
Symphony™ Clot Container
Company
IMPERATIVE CARE, INC.
Model
SYMPHONYCC
Catalog number
SYMPHONYCC
Device description
Symphony Clot Container
Published
2024-02-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRACatheter, Continuous Flush
QEWPeripheral Mechanical Thrombectomy With Aspiration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2
QEWPeripheral Mechanical Thrombectomy With AspirationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223216000
K250775000
K252057000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223216000Symphony Thrombectomy SystemTruvic Medical, Inc.2023-02-23QEW
K250775000Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy SystemImperative Care, Inc.2025-05-14QEW
K252057000Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy SystemImperative Care, Inc.2025-08-28QEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850032079164PackageGS16In Commercial Distribution
00850032079167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003207916410850032079164
00850032079167008500320791678500320791670850032079167

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place.

Contacts#

Phone, Email table
PhoneEmail
1-833-878-8422customerservice@imperativecare.com

Regulatory Flags#

DUNS number
080816678
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812212030764Zoom 4S CatheterICRC04S160ICRC04S1602025-11-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857136004293TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004392TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004408TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004415TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00885403542667TRUWAVEBecton, Dickinson And CompanyKRA2026-09-05
00885403530534FogartyBecton, Dickinson And CompanyKRA2026-08-14
00885403530541FogartyBecton, Dickinson And CompanyKRA2026-08-14
00885403530558FogartyBecton, Dickinson And CompanyKRA2026-08-14
00885403530572FogartyBecton, Dickinson And CompanyKRA2026-08-14
00885403530589FOGARTYBecton, Dickinson And CompanyKRA2026-08-14
00850013694099MicroGuideMicro Medical Solutions, Inc.KRA2026-04-24
00812339030807Pounce ™ XL ThrombectomySurmodics, Inc.QEW2024-11-13
B0902P0130B0Knight MicrocatheterZien Medical Technologies, LLCKRA2024-04-30
B0902P0130S0Knight MicrocatheterZien Medical Technologies, LLCKRA2024-04-30
B090E20130B0XO CathZien Medical Technologies, LLCKRA2024-04-30
B090E20130S0XO CathZien Medical Technologies, LLCKRA2024-04-30
00812339030760Pounce ™ LP ThrombectomySurmodics, Inc.QEW2024-03-19
00810123710430ClotTriever Sheath, 16 FrInari Medical, Inc.QEW2023-12-15
00810123710522Triever20 CurveInari Medical, Inc.KRA2023-12-15
00810123710522Triever20 CurveInari Medical, Inc.QEW2023-12-15
00812339030319Pounce Venous Thrombectomy SystemSurmodics, Inc.KRA2023-10-27
00812339030319Pounce Venous Thrombectomy SystemSurmodics, Inc.QEW2023-10-27
00812339030784Pounce ™ ThrombectomySurmodics, Inc.QEW2023-08-16
00850291007277ClotTriever XL CatheterInari Medical, Inc.QEW2023-05-09
00850291007277ClotTriever XL CatheterInari Medical, Inc.KRA2023-05-09
00850291007321Artix BGInari Medical, Inc.QEW2023-05-09
00850291007376Artix™ AXInari Medical, Inc.QEW2023-04-24
00850291007376Artix™ AXInari Medical, Inc.KRA2023-04-24
00812339030302Pounce™ Venous Thrombectomy SystemSurmodics, Inc.QEW2022-06-22
00812339030302Pounce™ Venous Thrombectomy SystemSurmodics, Inc.KRA2022-06-22