Reprocessed Carto Vizigo Bi-Directional Guiding Sheath— 510(k) K212165
Substantially EquivalentInnovative Health, LLC
FDA 510(k) clearance K212165 for Reprocessed Carto Vizigo Bi-Directional Guiding Sheath, Substantially Equivalent on 2022-03-10. Applicant: Innovative Health, LLC. Device class: 2.
Clearance details
- Applicant
- Innovative Health, LLC
- Product code
- Product code PNE
- Device class
- Class 2
- Regulation
- 21 CFR 870.1340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Scottsdale, AZ, US
Recent devices under product code PNE
view all- K250305 — Reprocessed Agilis NxT Steerable Introducer
- K250314 — Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer
- K232037 — Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath
- K230376 — Reprocessed Agilis NxT Steerable Introducer
- K170311 — Reprocessed Agilis NxT Steerable Introducer
More clearances from Innovative Health, LLC
view allData sourced from openFDA. This site is unofficial and independent of the FDA.