510(k) K170997 ยท DYB Introducer, Catheter
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath
| Applicant | Biosense Webster, Inc., Irvin CA, US |
| Decision | Substantially Equivalent, Jul 25, 2017 |
| Received | Apr 3, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170997
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 13, 2024 | Biosense Webster, Inc. CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502
The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerabl Open, Classified |
DYB | None listed |
| Apr 1, 2023 | Biosense Webster, Inc. Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile Open, Classified |
DYB | None listed |
| Apr 1, 2023 | Biosense Webster, Inc. Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile Open, Classified |
DYB | None listed |
| Jun 29, 2022 | Biosense Webster, Inc. CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart. Open, Classified |
DYB | None listed |
| Feb 26, 2021 | Biosense Webster, Inc. Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016253 - Product Usage: provide accessibility and maneuvera Completed |
DYB | None listed |
| Feb 26, 2021 | Biosense Webster, Inc. Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016260 - Product Usage: provide accessibility and maneuvera Completed |
DYB | None listed |
| Feb 26, 2021 | Biosense Webster, Inc. Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE EO, UDI: (01)10846835016277 - Product Usage: provide accessibility and maneuver Completed |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.