FDA.reportPublic FDA data

AFX Introducer System

Primary DI
00818009011381
Brand
AFX Introducer System
Company
Endologix LLC
Model
S17-45
Published
2014-09-24
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
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120212000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120212000AFX INTRODUCER SYSTEMEndologix, Inc.2012-02-09DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818009011381PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818009011381008180090113818180090113810818009011381

GMDN Terms#

Term, Definition table
TermDefinition
Haemostasis valveA noninvasive device designed as a conduit through which a small-diameter diagnostic/interventional device(s) can be introduced into or withdrawn from a patient's vasculature while preventing backflow of blood; it might in addition be intended for urinary applications. It is intended to be attached, typically via Luer-lock, to an invasively-placed catheter introducer (not included) and typically has a self-sealing lumen(s) [e.g., Touhy-Borst valve] and sideport for the introduction of solutions. It may include noninvasive guidewire accessories (e.g., guidewire introducer). It is not designed to be connected between tubing (i.e., not an in-line valve). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(949) 595-7200CustomerService@endologix.com

Regulatory Flags#

DUNS number
858560477
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850032145008ENDOCROSS DeviceENDOCROSSENDOCROSS2025-09-24
00850007370152Ovation iX Iliac Stent GraftTV-IL141280-JTV-IL141280-J2023-03-03
00850007370169Ovation iX Iliac Stent GraftTV-IL1412100-JTV-IL1412100-J2023-03-03
00850007370176Ovation iX Iliac Stent GraftTV-IL1412120-JTV-IL1412120-J2023-03-03
00850007370183Ovation iX Iliac Stent GraftTV-IL1412140-JTV-IL1412140-J2023-03-03
00850007370213Ovation iX Iliac Stent GraftTV-IL1414120-JTV-IL1414120-J2023-03-03
00850007370411Ovation iX Iliac Stent GraftTV-IL1412160-JTV-IL1412160-J2023-03-03
00850007370428Ovation iX Iliac Stent GraftTV-IL1414100-JTV-IL1414100-J2023-03-03
00850007370091Ovation iX Iliac Stent GraftTV-IL1428140-JTV-IL1428140-J2023-03-02
00850007370107Ovation iX Iliac Stent GraftTV-IL141480-JTV-IL141480-J2023-03-02
00850007370114Ovation iX Iliac Stent GraftTV-IL1410160-JTV-IL1410160-J2023-03-02
00850007370190Ovation iX Iliac Stent GraftTV-IL1428120-JTV-IL1428120-J2023-03-02
00850007370206Ovation iX Iliac Stent GraftTV-IL1428100-JTV-IL1428100-J2023-03-02
00850007370220Ovation iX Iliac Stent GraftTV-IL1414140-JTV-IL1414140-J2023-03-02
00850007370237Ovation iX Iliac Stent GraftTV-IL141680-JTV-IL141680-J2023-03-02
00850007370244Ovation iX Iliac Stent GraftTV-IL1416100-JTV-IL1416100-J2023-03-02
00850007370251Ovation iX Iliac Stent GraftTV-IL1416120-JTV-IL1416120-J2023-03-02
00850007370268Ovation iX Iliac Stent GraftTV-IL1416140-JTV-IL1416140-J2023-03-02
00850007370275Ovation iX Iliac Stent GraftTV-IL141880-JTV-IL141880-J2023-03-02
00850007370282Ovation iX Iliac Stent GraftTV-IL1418100-JTV-IL1418100-J2023-03-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450840597Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-27
06974949030920CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
06974949030944CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
10801902227246ARROWTELEFLEX INCORPORATEDDYB2026-08-27
10884450119836Prelude EASE™Merit Medical Systems, Inc.DYB2026-08-27
00884450838211Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-18
00199874352930Transseptal Puncture DevicePROTARYX MEDICAL INC.DYB2026-07-15
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATINGFREUDENBERG MEDICAL, LLCDYB2026-01-29
00850291007260Intri24 Introducer SheathInari Medical, Inc.DYB2023-03-20
10801902190519ARROWTELEFLEX INCORPORATEDDYB2021-09-02
04251244500641DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500719DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500801DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500818DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500832DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500849DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500856DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244501099DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244501075DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244501082DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500795DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2020-11-04
00389701012353R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012360R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012377R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012384R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
04251244500108DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500115DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500122DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500139DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500146DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30