FDA.reportPublic FDA data

Symphony™ Clot Container

Primary DI
10850032079164
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
New
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
QEWPeripheral Mechanical Thrombectomy With Aspiration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QEWPeripheral Mechanical Thrombectomy With AspirationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223216000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223216000Symphony Thrombectomy SystemTruvic Medical, Inc.2023-02-23QEW

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-833-878-8422customerservice@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
false
Sterilization required before use
false

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
00812212030795Ikon 14 GuidewireICGW014200SICGW014200S2025-11-24
00812212030801Ikon 14 GuidewireICGW014300SICGW014300S2025-11-24
00812212030818Ikon 14 Pro GuidewireICGW014200PICGW014200P2025-11-24
00812212030825Ikon 14 Pro GuidewireICGW014300PICGW014300P2025-11-24
00812212030832Ikon 18 GuidewireICGW018200SICGW018200S2025-11-24
00812212030856Ikon 18 Pro GuidewireICGW018200PICGW018200P2025-11-24
00812212030863Ikon 18 Pro GuidewireICGW018260PICGW018260P2025-11-24
00812212030887Ikon 24 GuidewireICGW024200SICGW024200S2025-11-24
00812212030900Ikon 24 Pro GuidewireICGW024200PICGW024200P2025-11-24
00812212030474Zoom CatheterICRC055137ICRC0551372022-07-08
00812212030498Zoom CatheterICRC045144ICRC0451442022-07-08
00812212030443Zoom CatheterICRC035158ICRC0351582021-11-17
00812212030450Zoom CatheterICRC071137ICRC0711372021-10-18
00812212030337TracStar LDP Large Distal PlatformICAC088095ICAC0880952021-09-22
00812212030344TracStar LDP Large Distal PlatformICAC088105ICAC0881052021-09-22
00850032079167Symphony™ Clot ContainerSYMPHONYCCSYMPHONYCC2024-02-02
00850032079211Symphony™ 16F 82cm CatheterSYMPHONY16F 82SYMPHONY16F822024-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083646028enVast 6.0 x 35 mm - Flow Restoration, 2 Drop Zones - 200 cm wireVesalioQEW2026-03-20
00850083646042enVast 4.5 x 37 mm - Flow Restoration, 2 Drop Zones - 200 cm wireVesalioQEW2026-03-20
00850083646059enVast 4.5 x 46 mm - Flow Restoration, 3 Drop Zones - 200 cm wireVesalioQEW2026-03-20
00850083646066enVast 4.0 x 30 mm - Flow Restoration, 2 Drop Zones - 200 cm wireVesalioQEW2026-03-20
00850044140015Helo Thrombectomy SystemEndovascular Engineering, Inc.QEW2026-03-13
00810169722213Indigo SystemPENUMBRA, INC.QEW2026-03-10
00810169722220Indigo SystemPENUMBRA, INC.QEW2026-03-10
00810169722237Indigo SystemPENUMBRA, INC.QEW2026-03-10
00810169722244Indigo SystemPENUMBRA, INC.QEW2026-03-10
00860008103819Recana Debulking CatheterIntervene, Inc.QEW2026-03-02
00860008103826Recana Collection Basket, 18mmIntervene, Inc.QEW2026-03-02
00860008103833Recana Collection Basket, 30mmIntervene, Inc.QEW2026-03-02
00860008103840Recana Introducer Sheath, 13Fr x 30cmIntervene, Inc.QEW2026-03-02
00860008103857Recana Introducer Sheath, 13Fr x 90cmIntervene, Inc.QEW2026-03-02
00860008103864Recana Introducer Sheath, 16Fr x 30cmIntervene, Inc.QEW2026-03-02
00860008103871Recana Introducer Sheath, 16Fr x 90cmIntervene, Inc.QEW2026-03-02
M917RVHD0RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.QEW2026-02-06
M917RVHD1RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.QEW2026-02-06
M917VRG7513B30RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.QEW2026-02-06
00810123710249Artix AXInari Medical, Inc.QEW2026-01-06
00810123710256Artix AXInari Medical, Inc.QEW2026-01-06
00810169722480Indigo System Lightning Bolt 16PENUMBRA, INC.QEW2025-11-24
00810169722497Indigo System Lightning Bolt 16PENUMBRA, INC.QEW2025-11-24
00810169722503Indigo System Lightning Bolt 16PENUMBRA, INC.QEW2025-11-24
00810169722510Indigo System Lightning Bolt 16PENUMBRA, INC.QEW2025-11-24
00810169722527Indigo System Lightning FlashPENUMBRA, INC.QEW2025-11-24
00810169722534Indigo System Lightning FlashPENUMBRA, INC.QEW2025-11-24
00810169722541Indigo System Lightning FlashPENUMBRA, INC.QEW2025-11-24
00810169722558Indigo System Lightning FlashPENUMBRA, INC.QEW2025-11-24
00763000849801Liberant™MEDTRONIC, INC.QEW2025-11-16