FDA.reportPublic FDA data

ARROW

Primary DI
10801902211504
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN926114
Catalog number
AI-06210-KS
Device description
Temporary Pacing Catheter with Shrouded Pins/Introducer Kit
Published
2022-06-13
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
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRFCatheter, Electrode Recording, Or Probe, Electrode RecordingCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K945229000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K945229000ARROW MULTIPOLAR INTRACARDIAC ELECTRODE CATHETERSArrow Intl., Inc.1995-08-08DRF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20801902211501PackageGS15In Commercial Distribution
10801902211504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190221150120801902211501
1080190221150410801902211504

GMDN Terms#

Term, Definition table
TermDefinition
Temporary cardiac pacing balloon catheterA sterile, flexible, balloon-tipped, tube designed to deliver temporary pacing stimuli to the heart; it may detect bioelectric signals from the heart. It is used in the atria and/or ventricles and has electrodes which are usually applied to the ventricles and connect to an external pacemaker that generates the electrical pacing impulses. It may be unipolar or bipolar and facilitate the display of electrocardiographic signals. It is used: 1) in an emergency during bradycardia or asystole until a pacemaker can be implanted to control the heart rate; 2) during and/or after surgery; or 3) during cardiac catheterization [e.g., electrophysiological (EP) examinations]. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

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
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

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Primary DI, Brand, Company table
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00818087023054MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00818087023061MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00818087023085MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00854277008135Vision-MR® Diagnostic CatheterImricor Medical Systems, Inc.DRF2026-05-06
04260192830601EasyMap MAP M (70mm)MedFact Engineering GmbHDRF2026-01-30
04260192832124EasyMap MAP L (80mm)MedFact Engineering GmbHDRF2026-01-30
04260192832131EasyMap MAP XL (90mm)MedFact Engineering GmbHDRF2026-01-30
24255650100406EasyConnect MAP CableMedFact Engineering GmbHDRF2026-01-30
00850012226000Axis Patient PatchesCardionxt IncDRF2025-12-10
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10801902004533ARROWTELEFLEX INCORPORATEDDRF2018-10-25
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00643169778184NAMEDTRONIC, INC.DRF2016-11-04
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