FDA.reportPublic FDA data

N/A

Primary DI
10841898137389
Brand
N/A
Company
INNOVATIVE HEALTH LLC
Model
N/A
Catalog number
VXAK85D1-DIL
Device description
Reprocessed VersaCross Connect Dilator for LAAC Access Solution D1 12F
Published
2026-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PNEReprocessed Catheter Introducer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNEReprocessed Catheter IntroducerCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232037000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232037000Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding SheathInnovative Health, LLC2024-04-04PNE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841898137389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084189813738910841898137389

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, reprocessedA sterile, flexible, single-lumen tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter or lead (e.g., pacing lead, balloon dilatation catheter) through its lumen, within the vascular system. It may be rigid or flexible, non-steerable or steerable, and the distal section of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, and is not a microcatheter (i.e., not intended to access superselective small vessels). It may include a disposable percutaneous introduction set. This is a previously used single-use device that has been processed for an additional single-use.

Contacts#

Phone, Email table
PhoneEmail
877-400-3740regulatory@innovative-health.com

Regulatory Flags#

DUNS number
015575953
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841898137365N/AN/AVXAK93D1-DIL2026-07-10
10841898137372N/AN/AVXAK85D0-DIL2026-07-10
10841898137273N/AN/A116574842026-06-01
10841898137280N/AN/A116574852026-06-01
10841898137174N/AN/A115108262026-05-07
10841898137266N/AN/A115108252026-05-07
10841898137297N/AN/AVXW-35-230-J2026-05-07
10841898137303N/AN/AVXW-35-180-J2026-05-07
10841898137310N/AN/AVXW-35-230-P2026-05-07
10841898137327N/AN/AVXW-35-180-P2026-05-07
10841898137587N/AN/AVXW-CFD-180J2026-05-07
10841898137594N/AN/AVXW-CFD-180P2026-05-07
10841898137600N/AN/AVXW-CFD-230P2026-05-07
10841898137617N/AN/AVXW-CWM-180J2026-05-07
10841898137624N/AN/AVXW-CWM-180P2026-05-07
10841898137631N/AN/AVXW-CWM-230P2026-05-07
10841898137242N/AN/AD1337032026-04-17
10841898123214N/AN/A104392362018-11-12
10841898123221N/AN/A104390722018-11-12
10841898123238N/AN/A104390112018-11-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841898137365N/AINNOVATIVE HEALTH LLCPNE2026-07-10
10841898137372N/AINNOVATIVE HEALTH LLCPNE2026-07-10
10841898131547N/AINNOVATIVE HEALTH LLCPNE2022-04-13
10841898131554N/AINNOVATIVE HEALTH LLCPNE2022-04-13
10841898131561N/AINNOVATIVE HEALTH LLCPNE2022-04-13
10841898130144N/AINNOVATIVE HEALTH LLCPNE2020-08-27
10841898130151N/AINNOVATIVE HEALTH LLCPNE2020-08-27
10841898130168N/AINNOVATIVE HEALTH LLCPNE2020-08-27
10841898130175N/AINNOVATIVE HEALTH LLCPNE2020-08-27
10841898130182N/AINNOVATIVE HEALTH LLCPNE2020-08-27
10841898130199N/AINNOVATIVE HEALTH LLCPNE2020-08-27
10841898130205N/AINNOVATIVE HEALTH LLCPNE2020-08-27
10841898130212N/AINNOVATIVE HEALTH LLCPNE2020-08-27
10841898120244N/AINNOVATIVE HEALTH LLCPNE2019-03-06
10841898128172N/AINNOVATIVE HEALTH LLCPNE2019-02-02
10841898128196N/AINNOVATIVE HEALTH LLCPNE2019-02-02
10841898120251N/AINNOVATIVE HEALTH LLCPNE2018-05-01
10841898120268N/AINNOVATIVE HEALTH LLCPNE2017-10-16
10841898120275N/AINNOVATIVE HEALTH LLCPNE2017-10-16
10841898120282N/AINNOVATIVE HEALTH LLCPNE2017-10-16
10888551044912NASTERILMED, INC.PNE2016-09-22
10888551044929NASTERILMED, INC.PNE2016-09-22
10888551044950NASTERILMED, INC.PNE2016-09-22