FDA.reportPublic FDA data

Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter

Primary DI
00850065047027
Brand
Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter
Company
Vein360 LLC
Model
88901RH
Catalog number
88901RH
Device description
Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter for Medline Renewal
Published
2024-08-02
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

Product Codes#

Code, Name table
CodeName
OWQReprocessed Intravascular Ultrasound Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWQReprocessed Intravascular Ultrasound CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230584000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230584000Vein360 Reprocessed Visions PV.035 Digital IVUS CatheterVein 360, LLC2023-06-06OWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850065047027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850065047027008500650470278500650470270850065047027

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular ultrasound imaging catheter, reprocessedA flexible, non-steerable tube with an ultrasound imaging transducer enclosed in a fluid-resistant or waterproof acoustically- and electrically-insulated housing, designed for insertion into the vascular system (i.e., peripheral vascular system, coronary artery) by an operator; it is not intended for intracardial insertion/imaging. Also known as a vascular ultrasound transducer, it includes a single or an array of transducer element(s). This is a previously used single-use device that has been processed for an additional single-use patient application.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080926907
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850065047003Vein360 Reprocessed Visions PV.014P RX Digital IVUS Catheter (014R)014RRH014RRH2024-08-02
00850065047010Vein360 Reprocessed Digital Intravascular (IVUS) Reprocessed Catheter PV .01886700RH86700RH2024-08-02
00850065047034Vein360 Reprocessed Visions PV.014P RX Digitial IVUS Catheter (014P)85910PRH85910PRH2024-08-02
00850065047041Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter85900PRH85900PRH2024-08-02
00850065047058Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter 85900PSTRH85900PSTRH2024-08-02
00860036000517Vein360 Reprocessed Visions PV.014P RX Digital IVUS Catheter (014R)VEN-PV-014RVEN-PV-014R2024-03-25
00860036000579Vein360 Reprocessed Visions PV.014P RX Digitial IVUS Catheter (014P)VEN-PV-014PVEN-PV-014P2024-03-25
00860036000586Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS CatheterVEN-PV-EEPVEN-PV-EEP2024-03-25
00860036000593Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS CatheterVEN-PV-EEPSTVEN-PV-EEPST2024-03-25
08600360005022Endovenous Radiofrequency Ablation (RFA) CatheterVEN-3-60VEN-3-602021-06-17
08600360005008Endovenous Radiofrequency Ablation (RFA) CatheterVEN-7-100VEN-7-1002021-06-17
08600360005107Endovenous Radiofrequency Ablation (RFA) CatheterVEN-7-60VEN-7-602021-06-17
00860036000524Reprocessed Visions PV.018 Digital IVUS CatheterVEN-PV-018VEN-PV-0182023-09-29
00860036000531Reprocessed Visions PV.035 Digital IVUS CatheterVEN-PV-035VEN-PV-0352023-08-29
00860036000548Endovenous Radiofrequency Ablation (RFA) CatheterVEN-7-60VEN-7-602021-10-26
00860036000555Endovenous Radiofrequency Ablation (RFA) CatheterVEN-7-100VEN-7-1002021-10-26
00860036000562Endovenous Radiofrequency Ablation (RFA) CatheterVEN-3-60VEN-3-602021-10-26
10860036000545Endovenous Radiofrequency Ablation (RFA) CatheterVEN-7-60VEN-7-602021-10-26
10860036000552Endovenous Radiofrequency Ablation (RFA) CatheterVEN-7-100VEN-7-1002021-10-26
10860036000569Endovenous Radiofrequency Ablation (RFA) CatheterVEN-3-60VEN-3-602021-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841898137273N/AINNOVATIVE HEALTH LLCOWQ2026-06-01
10841898137280N/AINNOVATIVE HEALTH LLCOWQ2026-06-01
10841898137174N/AINNOVATIVE HEALTH LLCOWQ2026-05-07
10841898137266N/AINNOVATIVE HEALTH LLCOWQ2026-05-07
10197344019557MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-10-15
10197344026500MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-10-15
10197344026517MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-10-15
10197344149537MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-09-08
10197344149544MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-09-08
10197344157303MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-07-11
10197344157280MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-07-08
10197344157273MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-07-08
20197344157287MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-07-08
10197344157297MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-07-08
00850044399130NES Reprocessed Visions PV .035 Digital IVUS CatheterNORTH EAST SCIENTIFIC INCOWQ2025-05-21
00850044399147NES Reprocessed Visions PV .014P RX Digital IVUS CatheterNORTH EAST SCIENTIFIC INCOWQ2025-05-21
00850044399154NES Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterNORTH EAST SCIENTIFIC INCOWQ2025-05-21
00850044399161NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter Short TipNORTH EAST SCIENTIFIC INCOWQ2025-05-21
00850044399208NES Reprocessed .014 Stryker CatheterNORTH EAST SCIENTIFIC INCOWQ2025-05-21
00850044399215NES Reprocessed Eagle Eye Platinum Long Tip StrykerNORTH EAST SCIENTIFIC INCOWQ2025-05-21
00850044399222NES Reprocessed Eagle Eye Platinum Short Tip StrykerNORTH EAST SCIENTIFIC INCOWQ2025-05-21
00850044399239NES Reprocessed .035 Stryker CatheterNORTH EAST SCIENTIFIC INCOWQ2025-05-21
00850044399178NES Reprocessed Visions PV .018 Digital IVUS CatheterNORTH EAST SCIENTIFIC INCOWQ2025-05-19
07613327664089Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OWQ2025-02-11
07613327664096Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OWQ2025-02-11
07613327664102Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OWQ2025-02-11
07613327664119Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OWQ2025-02-11
57613327664114Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OWQ2025-02-11
10841898134494N/AINNOVATIVE HEALTH LLCOWQ2024-11-06
B227RS889011NES Reprocessed .035 Stryker CatheterNORTH EAST SCIENTIFIC INCOWQ2024-08-16