FDA.reportPublic FDA data

VersaCross™ Steerable Access Solution

Primary DI
00685447019619
Brand
VersaCross™ Steerable Access Solution
Company
BOSTON SCIENTIFIC CORPORATION
Model
VSTK0103
Catalog number
VSTK0103
Device description
Steerable Access Solution
Published
2025-02-25
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

Product Codes#

Code, Name table
CodeName
OFKPercutaneous atrial catheter kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFKPercutaneous Atrial Catheter KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00685447019619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00685447019619006854470196196854470196190685447019619

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac transseptal access setA collection of nonimplantable, invasive devices intended to be used to puncture the interatrial septum during a transseptal catheterization procedure, and to create a conduit for the introduction of various cardiovascular catheters into the left side of the heart. It includes a vascular guide-catheter (which may be referred to as a steerable introducer) with a transseptal needle to create the puncture, and typically includes additional introduction assistive devices necessary for the procedure (e.g., stylet, guidewire, dilator). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729424246Contour™M0061802311202015-09-24
08714729457923Percuflex™M0061453600502015-09-24
08714729460282Percuflex™ PlusM0061751980602015-09-24
08714729460398Percuflex™ PlusM0061752500602015-09-24
08714729460657Percuflex™ PlusM0061752600502015-09-24
08714729461012Percuflex™ PlusM0061752650602015-09-24
08714729766629Polaris™ UltraM0061921401902015-09-24
08714729766735Polaris™ UltraM0061921441702015-09-24
08714729766759Polaris™ UltraM0061921451202015-09-24
08714729766766Polaris™ UltraM0061921451702015-09-24
08714729766803Polaris™ UltraM0061921501902015-09-24
08714729766841Polaris™ UltraM0061921521202015-09-24
08714729766919Polaris™ UltraM0061921541702015-09-24
08714729766926Polaris™ UltraM0061921541902015-09-24
08714729776307Contour™M0061802351702015-09-24
08714729776680Contour™M0061802301802015-09-24
08714729777137Polaris™ UltraM0061921401802015-09-24
08714729777199Polaris™ UltraM0061921501802015-09-24
08714729777205Polaris™ UltraM0061921511802015-09-24
08714729777441Polaris™ LoopM0061552250902015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956399396CARDINAL HEALTHCardinal Health 200, LLCOFK2026-04-27
10198956353244CARDINAL HEALTHCardinal Health 200, LLCOFK2026-04-09
10198956335189CARDINAL HEALTHCardinal Health 200, LLCOFK2026-02-12
10198956202665CARDINAL HEALTHCardinal Health 200, LLCOFK2025-10-20
10198956074125CARDINAL HEALTHCardinal Health 200, LLCOFK2025-06-26
50198956074123CARDINAL HEALTHCardinal Health 200, LLCOFK2025-06-26
10198956010772CARDINAL HEALTHCardinal Health 200, LLCOFK2025-04-25
50198956010770CARDINAL HEALTHCardinal Health 200, LLCOFK2025-04-25
10197106927946CARDINAL HEALTHCardinal Health 200, LLCOFK2025-03-20
50197106927944CARDINAL HEALTHCardinal Health 200, LLCOFK2025-03-20
00685447019466VersaCross Connect™ LAAC Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019473VersaCross Connect™ LAAC Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019480VersaCross Connect™ LAAC Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019497VersaCross Connect™ LAAC Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019503VersaCross Connect™ LAAC Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019558VersaCross™ Large Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019565VersaCross™ Large Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019572VersaCross™ Large Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019589VersaCross™ Large Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019596VersaCross™ Large Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019602VersaCross™ Steerable Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019626VersaCross™ Steerable Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019633VersaCross™ Steerable Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019640VersaCross™ Steerable Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019657VersaCross™ Steerable Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019664VersaCross™ Steerable Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019671VersaCross™ Steerable Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019688VersaCross™ Steerable Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019695VersaCross™ Steerable Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019701VersaCross™ Steerable Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25