FDA.reportPublic FDA data

VersaCross™ Steerable Access Solution

Primary DI
00685447019633
Brand
VersaCross™ Steerable Access Solution
Company
BOSTON SCIENTIFIC CORPORATION
Model
VSTK0106
Catalog number
VSTK0106
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
00685447019633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00685447019633006854470196336854470196330685447019633

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
00802526613876LATITUDE® NXT646064602020-04-09
08714729893431ROTAPRO™ AdvancerH74939299A02018-07-11
08714729999560ROTAPRO™H749394671250H7493946712502020-07-01
08714729999577ROTAPRO™H749394671500H7493946715002020-07-01
08714729999584ROTAPRO™H749394671750H7493946717502020-07-01
08714729999591ROTAPRO™H749394672000H7493946720002020-07-01
08714729999607ROTAPRO™H749394672150H7493946721502020-07-01
08714729999614ROTAPRO™H749394672250H7493946722502020-07-01
08714729999621ROTAPRO™H749394672380H7493946723802020-07-01
08714729999638ROTAPRO™H749394672500H7493946725002020-07-01
00191506062620RIVOS™M00553900M005539002026-06-25
08714729050650Entry KitM001503500M0015035002016-01-29
08714729082026SteeroCath-Dx™M0042028BL02016-09-24
08714729085249Electrophysiology CableM00490002016-09-24
08714729114659Greenfield™M001503000M0015030002015-09-24
08714729114666Greenfield™M001503010M0015030102015-09-24
08714729124993Greenfield™M001505010M0015050102015-09-24
08714729270249Electrophysiology CableM004901AS02016-09-24
08714729270256Electrophysiology CableM004901BS02016-09-24
08714729334996Electrophysiology CableM004921B02016-09-24

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
00685447019619VersaCross™ Steerable Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019626VersaCross™ 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