FDA.reportPublic FDA data

ARROW

Primary DI
20801902211631
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN926155
Catalog number
PL-00740
Device description
Arrow(R) GlideThru(R) Peel-Away Sheath over Dilator
Published
2022-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYBIntroducer, catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122854000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122854000ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCERArrow International (Subsidiary of Teleflex Inc.)2013-01-04DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20801902211631PackageGS110In Commercial Distribution
10801902211634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190221163120801902211631
1080190221163410801902211634

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
10801902226485ARROWIPNB00690ASK-21242-CWH12026-07-22
14026704624697RUSCHIPN04946312241102026-07-22
14026704911810PLEUR-EVACIPN927045S-1150-08LF2026-07-22
30801902193538ARROWIPN920132CS-15322-SPM2026-07-22
10841495149471QUIKCLOT1881882026-07-17
14026704645333WECKIPN9142504200232026-07-21
14026704714510LMA ATOMIZATIONIPN916119MAD300B2026-07-21
14026704930767QUIKCLOT4614612026-07-17
00801902102782ARROWIPN030321SAC-008222016-09-16
10841495149457QUIKCLOT1831832026-07-17
10841495149464QUIKCLOT1831832026-07-17
10841495149488QUIKCLOT1881882026-07-17
10841495149495QUIKCLOT3743742026-07-17
10841495149501QUIKCLOT3743742026-07-17
10841495149518QUIKCLOT4584582026-07-17
10841495149549QUIKCLOT4594592026-07-17
10841495149563QUIKCLOT4604602026-07-17
10841495149587QUIKCLOT4614612026-07-17
10841495149600QUIKCLOT467Z467Z2026-07-17
10841495149624QUIKCLOT4874872026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902226485ARROWTELEFLEX INCORPORATEDDYB2026-07-22
00850064198676Aligned Medical SolutionsAligned Medical SolutionsDYB2026-07-17
00850064198683Aligned Medical SolutionsAligned Medical SolutionsDYB2026-07-17
10884450114008Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-09
10884450119799Prelude EASE™Merit Medical Systems, Inc.DYB2026-06-09
10884450114855Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-08
00850084947001Genie MAXCULTIV8 1, LLCDYB2026-05-29
G440VIZ1750MultiflexVizaramed, Inc.DYB2026-04-09
04251244502768Catapult Guide SheathContract Medical International GmbHDYB2024-08-19
04251244502775Catapult Guide SheathContract Medical International GmbHDYB2024-08-19
04251244502782Catapult Guide SheathContract Medical International GmbHDYB2024-08-19
04251244501983Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244501990Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502003Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502010Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502027Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502034Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502041Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502058Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502065Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502072Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502089Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502096Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502102Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502119Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502126Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502133Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502140Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502157Catapult Guide SheathContract Medical International GmbHDYB2023-09-01
04251244502164Catapult Guide SheathContract Medical International GmbHDYB2023-09-01