FDA.reportPublic FDA data

Biotronik Fortress Introducer Sheath System

Primary DI
04251244503673
Brand
Biotronik Fortress Introducer Sheath System
Company
Contract Medical International GmbH
Model
5F; 45 cm; crossover
Catalog number
386590
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
14251244503670PackageGS15In Commercial Distribution
04251244503673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1425124450367014251244503670
04251244503673042512445036734251244503673

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 Diameter1.95Millimeter

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
04251244502768Catapult Guide Sheath4F, 130cm, Straight, hydrophilic coatedUS-34130-F-ST-H2024-08-19
04251244502775Catapult Guide Sheath5F, 130cm, Straight, hydrophilic coatedUS-35130-F-ST-H2024-08-19
04251244502782Catapult Guide Sheath6F, 130cm, Straight, hydrophilic coatedUS-36130-F-ST-H2024-08-19
14251244502765Catapult Guide Sheath4F, 130cm, Straight, hydrophilic coatedUS-34130-F-ST-H2024-08-19
14251244502772Catapult Guide Sheath5F, 130cm, Straight, hydrophilic coatedUS-35130-F-ST-H2024-08-19
14251244502789Catapult Guide Sheath6F, 130cm, Straight, hydrophilic coatedUS-36130-F-ST-H2024-08-19
04251244503604Biotronik Fortress Introducer Sheath System4F; 45 cm; straight3588142024-06-24
04251244503611Biotronik Fortress Introducer Sheath System4F; 100 cm; straight358815 2024-06-24
04251244503628Biotronik Fortress Introducer Sheath System4F; 45 cm; crossover358813 2024-06-24
04251244503635Biotronik Fortress Introducer Sheath System4F; 65 cm; straight444486 2024-06-24
04251244503642Biotronik Fortress Introducer Sheath System4F; 90 cm; straight4444852024-06-24
04251244503659Biotronik Fortress Introducer Sheath System5F; 45 cm; straight386591 2024-06-24
04251244503666Biotronik Fortress Introducer Sheath System5F; 100 cm; straight386592 2024-06-24
04251244503680Biotronik Fortress Introducer Sheath System5F; 65 cm; straight444484 2024-06-24
04251244503697Biotronik Fortress Introducer Sheath System5F; 90 cm; straight444483 2024-06-24
04251244503703Biotronik Fortress Introducer Sheath System6F; 45 cm; straight386594 2024-06-24
04251244503710Biotronik Fortress Introducer Sheath System6F; 100 cm; straight386595 2024-06-24
04251244503727Biotronik Fortress Introducer Sheath System6F; 45 cm; crossover386593 2024-06-24
04251244503734Biotronik Fortress Introducer Sheath System6F; 65 cm; straight444482 2024-06-24
04251244503741Biotronik Fortress Introducer Sheath System6F; 90 cm; straight444481 2024-06-24

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Primary DI, Brand, Company table
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10884450706708Prelude®Merit Medical Systems, Inc.DRE2026-06-03
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08498840011300VYGONVygon CorporationDYB2019-04-08
08498840011317VYGONVygon CorporationDYB2019-04-08
08498840011751VYGONVygon CorporationDYB2019-04-08
08498840011768VYGONVygon CorporationDYB2019-04-08
08498840011775VYGONVygon CorporationDYB2019-04-08
08498840011782VYGONVygon CorporationDYB2019-04-08
08498840011799VYGONVygon CorporationDYB2019-04-08
08498840011805VYGONVygon CorporationDYB2019-04-08
08498840011812VYGONVygon CorporationDYB2019-04-08
08498840012215VYGONVygon CorporationDYB2019-04-08
H965481030ENVINAVILYST MEDICAL, INC.DYB2019-01-03
07613327459210AXS VECTA 71Stryker CorporationDYB2018-10-26
07613327459227AXS VECTA 71Stryker CorporationDYB2018-10-26
07613327459234AXS VECTA 71Stryker CorporationDYB2018-10-26
00813502010664Introducer Kit for Impella®Oscor Inc.DYB2017-11-30
00813502010237Introducer Kit for Impella®Oscor Inc.DYB2017-11-18
00813502010244Introducer Kit for Impella®Oscor Inc.DYB2017-11-18
00813502010558Introducer Kit for Impella®Oscor Inc.DYB2017-11-18
H965481080NavylistNAVILYST MEDICAL, INC.DYB2017-08-07
H965355010ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355020ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355030ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355060ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355080ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355090ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355110ENVINAVILYST MEDICAL, INC.DYB2017-08-07