FDA.reportPublic FDA data

Biotronik Fortress Introducer Sheath System

Primary DI
04251244503680
Brand
Biotronik Fortress Introducer Sheath System
Company
Contract Medical International GmbH
Model
5F; 65 cm; straight
Catalog number
444484
Device description
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator.
Published
2024-06-24
Public version status
New
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
DREDilator, Vessel, For Percutaneous Catheterization
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153197000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153197000Fortress Introducer Sheath SYstemContract Medical International, GmbH2016-01-11DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14251244503687PackageGS15In Commercial Distribution
04251244503680PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1425124450368714251244503687
04251244503680042512445036804251244503680

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length65Centimeter
Lumen/Inner Diameter1.95Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+410448645111info.vi@biotronik.com

Regulatory Flags#

DUNS number
330926895
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
04251244500108DuraSheath Introducer Sheath System4F, 45cm, straigthFG-040452019-06-30
04251244500115DuraSheath Introducer Sheath System4F, 60cm, straigthFG-040602019-06-30
04251244500122DuraSheath Introducer Sheath System4F, 90cm, straigthFG-040902019-06-30
04251244500139DuraSheath Introducer Sheath System5F, 45cm, straigthFG-050452019-06-30
04251244500146DuraSheath Introducer Sheath System5F, 60cm, straigthFG-050602019-06-30
04251244500153DuraSheath Introducer Sheath System5F, 90cm, straigthFG-050902019-06-30
04251244500177DuraSheath Introducer Sheath System6F, 60cm, straigthFG-060602019-06-30
04251244500184DuraSheath Introducer Sheath System6F, 90cm, straigthFG-060902019-06-30
04251244500306DuraSheath Introducer Sheath System7F, 90cm, straigthFG-070902019-06-30
04251244500313DuraSheath Introducer Sheath System8F, 90cm, straigthFG-080902019-06-30
04251244500443DuraSheath Introducer Sheath System7F, 45cm, straigthFG-070452019-06-30
04251244500450DuraSheath Introducer Sheath System7F, 60cm, straigthFG-070602019-06-30
04251244500467DuraSheath Introducer Sheath System8F, 45cm, straigthFG-080452019-06-30
04251244500474DuraSheath Introducer Sheath System8F, 60cm, straigthFG-080602019-06-30
04251244500481DuraSheath Introducer Sheath System4F, 15cm, straigthFG-040152019-06-30
04251244500610DuraSheath Introducer Sheath System5F, 15cm, straigthFG-050152019-06-30
04251244500627DuraSheath Introducer Sheath System6F, 15cm, straigthFG-060152019-06-30
04251244500641DuraSheath Introducer Sheath System6F, 60cm, straight, firmFG-06060-F2021-04-20
04251244500658DuraSheath Introducer Sheath System6F, 90cm, straigth, firmFG-06090-F2019-02-12
04251244500719DuraSheath Introducer Sheath System6F, 15cm, straight, firmFG-06015-F2021-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450840597Prelude Roadster™Merit Medical Systems, Inc.DRE2026-08-27
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.DRE2026-08-18
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