FDA.reportPublic FDA data

ARROW

Primary DI
10801902201550
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN921210
Catalog number
SAC-01222
Device description
Arterial Catheterization Set
Published
2023-06-06
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093050000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093050000ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520Arrow Intl., Inc.2009-12-18DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20801902201557PackageGS110Not in Commercial Distribution
10801902201550PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190220155720801902201557
1080190220155010801902201550

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral artery cannulaA short, thin tube intended for short-term (<= 30 days) percutaneous access to a peripheral artery for invasive blood pressure monitoring and arterial blood sampling; it may in addition be intended for peripheral intravenous (IV) or subcutaneous use for blood sampling or administration of fluid/medication. Also referred to as a peripheral arterial catheter, it is used with an external blood pressure transducer (not included) to enable pressure measurements; it does not include electronic sensors and is not intended for advancement into the vasculature. It may include devices dedicated to introduction/function (e.g., introducer needle, guidewire, adaptor). This is a single-use device.

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
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14026704936882WECK5442345442342026-10-20
14026704936899WECK5442445442442026-10-20
14026704936905WECK5442545442542026-10-20
14026704936912WECK5442325442322026-10-20
14026704936929WECK5442425442422026-10-20
14026704936936WECK5442525442522026-10-20
14026704936943WECK5442325442322026-10-20
14026704936950WECK5442345442342026-10-20
14026704936967WECK5442425442422026-10-20
14026704936974WECK5442445442442026-10-20
14026704936981WECK5442525442522026-10-20
14026704936998WECK5442545442542026-10-20
30801902124921ARROWIPN037387ASK-04100-AMC-S12026-10-13
14026704937001WECK5442405442402026-03-30
10841156108441ONCONTROLIPN9190129402-VC-0062022-01-21
10841156108458ONCONTROLIPN9190139403-VC-0062022-01-21
10841156108465ONCONTROLIPN9190149407-VC-0062022-01-21
10841156108472ONCONTROLIPN9190169411-VC-0062021-10-29
10841156108489ONCONTROLIPN9190179425-VC-0062022-01-20
10841156108496ONCONTROLIPN9190189451-VC-0062021-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00802526625008ACUITY™BOSTON SCIENTIFIC CORPORATIONDQY2026-10-15
0086001552773870 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
0086001552774570 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
00810068568998Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00840303713104Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00884450416723SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450422755SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450423110SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450427170SureCrossMerit Medical Systems, Inc.DQY2026-09-22
10886704074892ENVOYCerenovus, Inc.DQY2026-09-19
00857545008394ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008400ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008431ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008448ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQY2026-02-24
08718122013984Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122028896Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122013915Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
10841156111250GUIDELINERTELEFLEX INCORPORATEDDQY2025-07-14
00857545008158ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008165ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008172ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008189ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008196ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008202ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008219ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008226ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008233ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008240ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008257ZebraQ'APEL MEDICAL LLCDQY2025-01-03