FDA.reportPublic FDA data

TracStar LDP Large Distal Platform

Primary DI
00812212030337
Brand
TracStar LDP Large Distal Platform
Company
IMPERATIVE CARE, INC.
Model
ICAC088095
Catalog number
ICAC088095
Device description
TracStar LDP, 95 cm
Published
2021-09-22
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
DQYCatheter, Percutaneous
NRYCatheter, Thrombus Retriever
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
NRYCatheter, Thrombus RetrieverCardiovascular2
QJPCatheter, Percutaneous, NeurovasculatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212224000
K240948000
K242672000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212224000TracStar LDP Large Distal Platform; Zoom 88 Large Distal PlatformImperative Care, Inc.2021-09-20QJP
K240948000TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform SupportImperative Care, Inc.2024-06-06QJP
K242672000Zoom SystemImperative Care, Inc.2025-01-14NRY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812212030337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812212030337008122120303378122120303370812212030337

GMDN Terms#

Term, Definition table
TermDefinition
Vascular microcatheterA sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Length95Centimeter
Lumen/Inner Diameter0.088Inch
Outer Diameter0.11Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00 Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
Special Storage Condition, Specify00Store in a cool, dry place at room temperature.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080816678
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
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
00812212030344TracStar LDP Large Distal PlatformICAC088105ICAC0881052021-09-22
00850032079167Symphony™ Clot ContainerSYMPHONYCCSYMPHONYCC2024-02-02
00850032079211Symphony™ 16F 82cm CatheterSYMPHONY16F 82SYMPHONY16F822024-08-09
00850032079174Symphony™ Advance™ Long DilatorADVANCEADVANCE2024-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902189452ARROWTELEFLEX INCORPORATEDDQY2026-08-01
10801902218145ARROWTELEFLEX INCORPORATEDDQY2026-08-01
10801902219692ARROWTELEFLEX INCORPORATEDDQY2026-08-01
10801902219708ARROWTELEFLEX INCORPORATEDDQY2026-08-01
10801902219715ARROWTELEFLEX INCORPORATEDDQY2026-08-01
10801902220445ARROWTELEFLEX INCORPORATEDDQY2026-08-01
00850074235132Toro 88 Superbore CatheterToro Neurovascular, Inc.QJP2026-07-31
08718122006153Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122006160Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122008188Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122008195Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122013922Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122014103Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122028902Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
10841156108915TRAPLINERTELEFLEX INCORPORATEDDQY2026-07-30
10801902196719ARROWTELEFLEX INCORPORATEDDQY2026-07-29
10841156108892TRAPLINERTELEFLEX INCORPORATEDDQY2026-07-29
00884450419922SureCrossMerit Medical Systems, Inc.DQY2026-07-24
10841156108908TRAPLINERTELEFLEX INCORPORATEDDQY2026-07-23
06934955914713Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914720Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914737Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914744Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914751Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914768Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914775Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914782Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914799Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914805Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914812Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20