Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PIVO

K-Number: K190604 · 2019-05-13

ApplicantVelano Vascular
Decision Date2019-05-13
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PIVO is the device name listed in this FDA 510(k) record. The listed applicant is Velano Vascular. It received FDA 510(k) clearance on 2019-05-13 under 510(k) number K190604. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIVO?

PIVO is a medical device that received FDA 510(k) clearance on 2019-05-13. The listed applicant is Velano Vascular. The 510(k) number is K190604.

When did PIVO receive FDA 510(k) clearance?

PIVO received FDA 510(k) clearance on 2019-05-13, under 510(k) number K190604.

Who is the listed applicant for PIVO?

The FDA 510(k) record lists Velano Vascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PIVO?

The FDA product code for PIVO is JKA.

Other records listing Velano Vascular as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201237Velano Vascular Blood Collection AdapterK200439Velano ExT Extension SetK193569PIVO(TM)K182897Velano Vascular Q2 Extension SetK163508PIVOK152924TIVA¿

View all 7 devices →

Related Devices (Code: JKA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd.K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and CompanyK252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and CompanyK252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and CompanyK252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesBecton, Dickinson and CompanyK251812Steripath® Flow™ Blood Collection SystemMagnolia Medical Technologies

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑