FDA.reportPublic FDA data

N/A

Primary DI
10841898137303
Brand
N/A
Company
INNOVATIVE HEALTH LLC
Model
N/A
Catalog number
VXW-35-180-J
Device description
Reprocessed VersaCross RF Wire and Connector Cable 180 cm J tip
Published
2026-05-07
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
QLZSeptostomy Catheter, Reprocessed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QLZSeptostomy Catheter, ReprocessedCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213584000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213584000Reprocessed NRG Transseptal NeedleInnovative Health, LLC2023-04-04QLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841898137303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084189813730310841898137303

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac transseptal access electrosurgical catheter, reprocessedA flexible tube intended to be used during a transseptal catheterization procedure to: 1) apply radio-frequency alternating current in a monopolar configuration, to puncture the interatrial septum and gain access to the left atrium; and 2) provide a fluid path to facilitate aspiration, injection/infusion, blood sampling, and/or pressure monitoring; it is not intended for cardiac ablation or to accommodate a needle in its lumen. It has a distal monopolar electrode. This is a previously used single-use device that has been processed for an additional single-use patient application.

Contacts#

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

Regulatory Flags#

DUNS number
015575953
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841898137174N/AN/A115108262026-05-07
10841898137266N/AN/A115108252026-05-07
10841898137297N/AN/AVXW-35-230-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
10841898123245N/AN/A104385772018-11-12
10841898110108N/AN/A101359362016-11-04
10841898110115N/AN/A101359102016-11-04
10841898110092N/AN/A082557902016-11-04
10841898110122N/AN/A100433422016-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841898137297N/AINNOVATIVE HEALTH LLCQLZ2026-05-07
10841898137310N/AINNOVATIVE HEALTH LLCQLZ2026-05-07
10841898137327N/AINNOVATIVE HEALTH LLCQLZ2026-05-07
10841898137587N/AINNOVATIVE HEALTH LLCQLZ2026-05-07
10841898137594N/AINNOVATIVE HEALTH LLCQLZ2026-05-07
10841898137600N/AINNOVATIVE HEALTH LLCQLZ2026-05-07
10841898137617N/AINNOVATIVE HEALTH LLCQLZ2026-05-07
10841898137624N/AINNOVATIVE HEALTH LLCQLZ2026-05-07
10841898137631N/AINNOVATIVE HEALTH LLCQLZ2026-05-07
10841898130809N/AINNOVATIVE HEALTH LLCQLZ2020-09-24
10841898130823N/AINNOVATIVE HEALTH LLCQLZ2020-09-24
10841898130830N/AINNOVATIVE HEALTH LLCQLZ2020-09-24
10841898130854N/AINNOVATIVE HEALTH LLCQLZ2020-09-24