510(k) K161183 ยท DYB Introducer, Catheter
Halo One Thin-Walled Guiding Sheath
| Applicant | C.R. Bard, Inc., Enniscorthy, IE |
| Decision | Substantially Equivalent, Jun 3, 2016 |
| Received | Apr 27, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161183
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 18, 2017 | BARD PERIPHERAL VASCULAR, INC Halo One 5F Introducer Sheath 45 cm
Product Code: HAL545
The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheathand introducer sheath. The Halo One Thin-Walled Guiding Terminated |
DYB | None listed |
| Jan 18, 2017 | BARD PERIPHERAL VASCULAR, INC Halo One 5F Introducer Sheath 90 cm
Product Code: HAL590
Product Usage:
The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo One Th Terminated |
DYB | None listed |
| Jan 18, 2017 | BARD PERIPHERAL VASCULAR, INC Halo One 5F Introducer Sheath 10 cm 5 pack
Product Code: HAL510F
Product Usage:
The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.