FDA.reportPublic FDA data

ARROW

Primary DI
10801902161991
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN915327
Catalog number
IAK-S7IT
Device description
Percutaneous Insertion Tray
Published
2021-08-20
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
DSPSystem, balloon, intra-aortic and control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSPSystem, Balloon, Intra-Aortic And ControlCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981660000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981660000Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon CathetersC.R. Bard, Inc.1998-10-16DSP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801902161991PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080190216199110801902161991

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14026704945310RUSCH116411642026-07-24
14026704945327RUSCH116511652026-07-24
14026704945334RUSCH116611662026-07-24
14026704945341RUSCH116711672026-07-24
14026704945358RUSCH116811682026-07-24
14026704945365RUSCH116911692026-07-24
14026704945372RUSCH117011702026-07-24
14026704945389RUSCH117111712026-07-24
14026704930651QUIKCLOT1831832026-07-17
14026704930675QUIKCLOT1881882026-07-17
14026704930736QUIKCLOT4594592026-07-17
10801902213188ARROWIPN927188DLX-200-CURV2026-07-23
10841156108908TRAPLINERIPN91750955672026-07-23
10841156111311LANGSTONIPN93013555402026-07-23
14026704944450RUSCH2205000602205000602026-07-23
14026704945402RUSCH2204001402204001402026-07-23
14026704945419RUSCH2204001602204001602026-07-23
14026704945426RUSCH2205000802205000802026-07-23
14026704945617RUSCH2204000802204000802026-07-23
14026704945624RUSCH2204001002204001002026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902223729ARROWTELEFLEX INCORPORATEDDSP2025-10-02
10801902223859ARROWTELEFLEX INCORPORATEDDSP2025-10-02
10801902219609ARROWTELEFLEX INCORPORATEDDSP2025-04-30
20801902219606ARROWTELEFLEX INCORPORATEDDSP2025-04-30
10607567113432CARDIOSAVE HYBRID, 3.1 EDITIONDatascope Corp.DSP2024-09-09
10607567113449CARDIOSAVE RESCUE, 3.1 EDITIONDatascope Corp.DSP2024-09-09
10607567114187"CARDIOSAVE HYBRID - TYPE ""N"" PLUG"Datascope Corp.DSP2024-09-09
10607567107585YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KITDATASCOPE CORP.DSP2024-08-12
10607567107592YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA)DATASCOPE CORP.DSP2024-08-12
10607567107608YAMATO PLUS-R 35cc IAB WITH ACCESSORIES AND RETRACTION KITDATASCOPE CORP.DSP2024-08-12
10607567107639YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA)DATASCOPE CORP.DSP2024-08-12
10607567111537Catheter Extender for Yamato Plus IABs - 10 PackDATASCOPE CORP.DSP2024-08-12
10607567111711TRANS-RAY PLUS 7.5Fr 35cc IAB WITH ACCESSORIESDATASCOPE CORP.DSP2024-08-12
10607567111728TRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIESDATASCOPE CORP.DSP2024-08-12
10607567104713CABLE,EXTERNAL SIGNAL,IABPDatascope Corp.DSP2024-07-26
10607567112817CARDIOSAVE LI-ION SINGLE BTTY TRANSPORTDatascope Corp.DSP2024-07-26
10607567113760CABLE ASSEMBLY, BLOOD PRESSURE TRANSDUCEDatascope Corp.DSP2024-07-26
10607567113777CABLE,LOW LEVEL OUTPUT,PHILIPSDatascope Corp.DSP2024-07-26
10607567113784CABLE,LOW LEVEL OUTPUT,GEDatascope Corp.DSP2024-07-26
10607567113807"CABLE,INTERFACE,1/4-1/4"",30'"Datascope Corp.DSP2024-07-26
10607567113814"CABLE, INTERFACE .25"" PLUG TO .25"" PLUG 30"Datascope Corp.DSP2024-07-26
10607567113821CABLE, INTERFACE 1/4” PLUG TO 1/8” PLUG,Datascope Corp.DSP2024-07-26
10607567113845CABLE INTERFACE 1/4” BIFURCATED PLUGS TO 6Datascope Corp.DSP2024-07-26
10607567113852"CABLE INTERFACE, 1/4"" PLUG TO TT-253 PLU"Datascope Corp.DSP2024-07-26
10607567113869AC PWR CORD,NEMA 5-15P TYPE BDatascope Corp.DSP2024-07-26
10607567113975COVER,CARDIOSAVE RAINDatascope Corp.DSP2024-07-26
10607567114262CABLE,LOW LEV OUTPUT,DATASCOPEDatascope Corp.DSP2024-07-26
10607567114279CABLE,LL OUTPUT,UN-TERMINATEDDatascope Corp.DSP2024-07-26
10801902218909ARROWTELEFLEX INCORPORATEDDSP2024-04-29
10801902218916ARROWTELEFLEX INCORPORATEDDSP2024-04-29