FDA.reportPublic FDA data

510(k) K212165

Device
Reprocessed Carto Vizigo Bi-Directional Guiding Sheath
Applicant
Innovative Health, LLC.
510(k) number
K212165
Product code
PNE  
Decision
Substantially Equivalent (SESE)
Decision date
2022-03-10
Date received
2021-07-12
Regulation
870.1340
Classification name
Reprocessed Catheter Introducer
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Rick Ferreira
Address
1435 N. Hayden Rd. Suite 100 Scottsdale AZ US 85257 85257

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PNE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250305Reprocessed Agilis NxT Steerable IntroducerInnovative Health2026-01-07
K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc.2025-12-19
K232037Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding SheathInnovative Health, LLC2024-04-04
K230376Reprocessed Agilis NxT Steerable IntroducerInnovative Health, LLC2023-08-07
K170311Reprocessed Agilis NxT Steerable IntroducerInnovative Health, LLC2017-06-02
K152090Reprocessed Steerable IntroducerSterilmed, Inc.2016-03-23

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases