FDA.reportPublic FDA data

Prodigy™ Catheter

Primary DI
08500320790046
Brand
Prodigy™ Catheter
Company
IMPERATIVE CARE, INC.
Model
PRODIGY5F
Catalog number
PRODIGY5F
Device description
5F Prodigy™ CatheterLength: 160 cmInner Diameter: 0.055 inOuter Diameter: 0.067 in (1.70 mm)
Published
2022-04-18
Public version status
Update
Distribution status
Not 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
QEWPeripheral Mechanical Thrombectomy With Aspiration

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K214114000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K214114000Prodigy Thrombectomy SystemTruvic Medical, Inc.2022-04-06QEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08500320790046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08500320790046085003207900468500320790046

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy suction catheterA sterile 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 and stented blood vessels, native and synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) typically achieved with the use of an included syringe(s) attached to the proximal end of the catheter, or connection to a dedicated suction pump system. Collection baskets may also be included to obtain filtered blood specimens for analyses. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Inner Diameter0.055Inch
Catheter Length160Centimeter
Outer Diameter0.067Inch

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

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Primary DI, Brand, Company table
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00860008103871Recana Introducer Sheath, 16Fr x 90cmIntervene, Inc.QEW2026-03-02
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