FDA.reportPublic FDA data

VersaCross™ Large Access Solution

Primary DI
00685447019596
Brand
VersaCross™ Large Access Solution
Company
BOSTON SCIENTIFIC CORPORATION
Model
VLAK0114
Catalog number
VLAK0114
Device description
Large 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
00685447019596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00685447019596006854470195966854470195960685447019596

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
08714729142201EndoVive Low Profile Replacement ButtonM005627702016-09-24
08714729142218EndoVive Low Profile Replacement ButtonM005628302016-09-24
08714729149200EndoVive™ One Step Button™M00568450M005684502018-09-07
08714729149217EndoVive™ One Step Button™M00568470M005684702018-09-07
08714729149224EndoVive™ One Step Button™M00568500M005685002018-09-07
08714729149231EndoVive™ One Step Button™M00568520M005685202018-09-07
08714729149934EndoVive™ One Step Button™M00568480M005684802018-09-07
08714729149941EndoVive™ One Step Button™M00568530M005685302018-09-07
08714729150084EndoVive™ One Step Button™M00568460M005684602018-09-07
08714729151081EndoVive™ One Step Button™M00568510M005685102018-09-07
08714729284017EndoVive Low Profile Replacement ButtonM005627602016-09-24
08714729284024EndoVive Low Profile Replacement ButtonM005627802016-09-24
08714729284031EndoVive Low Profile Replacement ButtonM005627902016-09-24
08714729284048EndoVive Low Profile Replacement ButtonM005628002016-09-24
08714729284062EndoVive Low Profile Replacement ButtonM005628202016-09-24
08714729284079EndoVive Low Profile Replacement ButtonM005628402016-09-24
08714729284086EndoVive Low Profile Replacement ButtonM005628502016-09-24
08714729821717Radial Jaw 4M005151802016-09-24
08714729821731Radial Jaw 4M005151902016-09-24
08714729821748Radial Jaw 4M005152002016-09-24

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
00685447019602VersaCross™ Steerable Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019619VersaCross™ 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