FDA.reportPublic FDA data

Symphony™ 16F 82cm Catheter

Primary DI
00850032079211
Brand
Symphony™ 16F 82cm Catheter
Company
IMPERATIVE CARE, INC.
Model
SYMPHONY16F 82
Catalog number
SYMPHONY16F82
Device description
16F 82cm Symphony™ Catheter w/ Dilator
Published
2024-08-09
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
00850032079211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850032079211008500320792118500320792110850032079211

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 Working Length82Centimeter
Introducer Sheath Compatibilit16French

Storage And Handling#

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

Sterilization Methods#

Method table
Method

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

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Primary DI, Brand, Company table
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00885403523598VAMPBecton, Dickinson And CompanyKRA2026-07-31
00885403523734VAMPBecton, Dickinson And CompanyKRA2026-07-31
00885403530565FogartyBecton, Dickinson And CompanyKRA2026-07-31
00885403542766TruWave, VAMP PlusBecton, Dickinson And CompanyKRA2026-07-31
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00690103218633SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCKRA2026-03-16
00812339030807Pounce ™ XL ThrombectomySurmodics, Inc.QEW2024-11-13
00812339030760Pounce ™ LP ThrombectomySurmodics, Inc.QEW2024-03-19
00812339030319Pounce Venous Thrombectomy SystemSurmodics, Inc.KRA2023-10-27
00812339030319Pounce Venous Thrombectomy SystemSurmodics, Inc.QEW2023-10-27
00812339030784Pounce ™ ThrombectomySurmodics, Inc.QEW2023-08-16
00812339030302Pounce™ Venous Thrombectomy SystemSurmodics, Inc.QEW2022-06-22
00812339030302Pounce™ Venous Thrombectomy SystemSurmodics, Inc.KRA2022-06-22
07640132622690M-CATH FlexyAcrostak (Schweiz) AGKRA2021-11-01
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