FDA.reportPublic FDA data

Biotronik Fortress Introducer Sheath System

Primary DI
04251244500030
Brand
Biotronik Fortress Introducer Sheath System
Company
Contract Medical International GmbH
Model
45 cm, 4F Crossover
Catalog number
358813
Device description
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2) dilators.
Published
2016-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K100799000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100799000FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815Contract Medical Intl. GmbH2011-02-25DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14251244500037PackageGS15In Commercial Distribution
04251244500030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1425124450003714251244500037
04251244500030042512445000304251244500030

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
Length45Centimeter
Lumen/Inner Diameter1.62Millimeter

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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251244501983Catapult Guide Sheath4F, 45cm, straight, hydrophilic coatedUS-34045-F-ST-H2023-09-01
04251244501990Catapult Guide Sheath4F, 60cm, straight, hydrophilic coatedUS-34060-F-ST-H2023-09-01
04251244502003Catapult Guide Sheath4F, 90cm, straight, hydrophilic coatedUS-34090-F-ST-H2023-09-01
04251244502010Catapult Guide Sheath5F, 15cm, straight, hydrophilic coatedUS-35015-F-ST-H2023-09-01
04251244502027Catapult Guide Sheath5F, 45cm, straight, hydrophilic coatedUS-35045-F-ST-H2023-09-01
04251244502034Catapult Guide Sheath5F, 45cm, Multipurpose, hydrophilic coatedUS-35045-F-MP-H2023-09-01
04251244502041Catapult Guide Sheath5F, 45cm, RDC, hydrophilic coatedUS-35045-F-RDC-H2023-09-01
04251244502058Catapult Guide Sheath5F, 45cm, Hockey stick, hydrophilic coatedUS-35045-F-HS-H2023-09-01
04251244502065Catapult Guide Sheath5F, 60cm, straight, hydrophilic coatedUS-35060-F-ST-H2023-09-01
04251244502072Catapult Guide Sheath5F, 90cm, straight, hydrophilic coatedUS-35090-F-ST-H2023-09-01
04251244502089Catapult Guide Sheath6F, 15cm, straight, hydrophilic coatedUS-36015-F-ST-H2023-09-01
04251244502096Catapult Guide Sheath6F, 45cm, straight, hydrophilic coatedUS-36045-F-ST-H2023-09-01
04251244502102Catapult Guide Sheath6F, 45cm, Multipurpose, hydrophilic coatedUS-36045-F-MP-H2023-09-01
04251244502119Catapult Guide Sheath6F, 45cm, LIMA, hydrophilic coatedUS-36045-F-LIMA-H2023-09-01
04251244502126Catapult Guide Sheath6F, 45cm, RDC, hydrophilic coatedUS-36045-F-RDC-H2023-09-01
04251244502133Catapult Guide Sheath6F, 45cm, Hockey stick, hydrophilic coatedUS-36045-F-HS-H2023-09-01
04251244502140Catapult Guide Sheath6F, 60cm, straight, hydrophilic coatedUS-36060-F-ST-H2023-09-01
04251244502157Catapult Guide Sheath6F, 90cm, straight, hydrophilic coatedUS-36090-F-ST-H2023-09-01
04251244502164Catapult Guide Sheath6F, 90cm, Multipurpose, hydrophilic coatedUS-36090-F-MP-H2023-09-01
04251244502171Catapult Guide Sheath6F, 90cm, RDC, hydrophilic coatedUS-36090-F-RDC-H2023-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00685447005285TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005292TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005308TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005315TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005322TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005339TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005346TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005353TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005360TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005377TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005384TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005391TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005407TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005414TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005421TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005438TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005445TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005452TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005469TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005476TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
10801902190519ARROWTELEFLEX INCORPORATEDDYB2021-09-02
00685447005605SupraCross Steerable SheathBaylis Médicale Cie IncDYB2021-04-19
00685447005612SupraCross Steerable SheathBaylis Médicale Cie IncDYB2021-04-19
00685447005629SupraCross Steerable SheathBaylis Médicale Cie IncDYB2021-04-19
00685447005643SureFlex Steerable Guiding SheathBaylis Médicale Cie IncDYB2021-04-19
00389701012353R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012360R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10