FDA.reportPublic FDA data

INT,SlideCath

Primary DI
26950900998977
Brand
INT,SlideCath
Company
Shanghai Kindly Medical Instruments Co., Ltd.
Model
ACST5F1065
Device description
5F*65cm ,straight
Published
2023-09-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQOCatheter, Intravascular, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201929000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201929000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26950900998977PackageGS15In Commercial Distribution
46950900998971PackageGS160In Commercial Distribution
06950900998973PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2695090099897726950900998977
4695090099897146950900998971
06950900998973069509009989736950900998973

GMDN Terms#

Term, Definition table
TermDefinition
Angiographic catheter, single-useA thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
420827639
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
true
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
06950900900693INT,SlideCathACJL605F11252023-09-11
06950900900709INT,SlideCathACJL606F11252023-09-11
06950900900716INT,SlideCathACJR304F11002023-09-11
06950900900723INT,SlideCathACJR307F11002023-09-11
06950900900730INT,SlideCathACJR355F11252023-09-11
06950900900747INT,SlideCathACJR356F11252023-09-11
06950900900754INT,SlideCathACJR405F11252023-09-11
06950900900761INT,SlideCathACJR406F11252023-09-11
06950900900778INT,SlideCathACJR455F11002023-09-11
06950900900785INT,SlideCathACJR456F11002023-09-11
06950900900792INT,SlideCathACJR456F11252023-09-11
06950900900808INT,SlideCathACJR457F11002023-09-11
06950900900815INT,SlideCathACJR505F11252023-09-11
06950900900822INT,SlideCathACJR506F11252023-09-11
06950900900839INT,SlideCathACJR605F11252023-09-11
06950900900846INT,SlideCathACJR606F11252023-09-11
06950900900853INT,SlideCathACTIG24F11002023-09-11
06950900900860INT,SlideCathACTIG25F11002023-09-11
06950900900877INT,SlideCathACTIG27F11002023-09-11
06950900900884INT,SlideCathACTIG34F11002023-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842429108574BOBBY/SOFIA KitMicrovention, Inc.DQO2025-04-30
00842429108444SofiaMicrovention, Inc.DQO2024-10-18
00842429108451SofiaMicrovention, Inc.DQO2024-10-18
00842429108468SofiaMicrovention, Inc.DQO2024-10-18
00763000541194RistTMMicro Therapeutics, Inc.DQO2022-05-01
00763000541200RistTMMicro Therapeutics, Inc.DQO2022-05-01
00763000541217RistTMMicro Therapeutics, Inc.DQO2022-05-01
00763000413767Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413774Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413781Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413798Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413804Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413811Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413828Rist™Micro Therapeutics, Inc.DQO2020-10-05
00816777025913Sofia 5F-125cm STRMicrovention, Inc.DQO2018-08-07
00816777025920Sofia 5F-115cm STRMicrovention, Inc.DQO2018-08-07
00857688007278Respiguide Delivery SystemRESPICARDIA, INC.DQO2018-04-30
00884450089194EmboCath® PlusBIOSPHERE MEDICALDQO2017-05-11
00884450089200EmboCath® PlusBIOSPHERE MEDICALDQO2017-05-11
00866749000202Morph Universal Deflectable Guide CatheterBIOCARDIA, INC.DQO2016-10-10
08714729200567Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200574Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200581Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200598Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200604Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200611Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200628Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200635Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200659Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200666Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24