510(k) K183655 ยท DYB Introducer, Catheter
VersaCross Transseptal Sheath
| Applicant | Baylis Medical Company, Inc., Mississauga, CA |
| Decision | Substantially Equivalent, May 20, 2019 |
| Received | Dec 27, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183655
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2025 | Boston Scientific Corporation VersaCross Access Solution (VXSK),
Product Description and ID:
VXSK (180J RF WIRE 63CM/45DEG/D0)
VXSK0101
VXSK (180J RF WIRE 63CM/45DEG/D1)
VXSK0102
VXSK (180J RF WIRE 63CM/55DEG/D0)
VXSK0103
VXSK (1 Open, Classified |
DXF | None listed |
| Jul 10, 2025 | Boston Scientific Corporation VersaCross Transseptal Sheath Kit (VXS)
Product Description/IDs
VXS0201
VXS 63CM/45DEG/D0 SHEATH
VXS2112
VERSACROSS SHEATH (63CM 45DEG D0)-J
Used for the percutaneous introduction of various types o Open, Classified |
DXF | None listed |
| Jul 10, 2025 | Boston Scientific Corporation Torflex Transseptal Guiding Sheath Kit (TFK-M)
TF85-32-63-45
TORFLEX 8.5F 63CM 45DEG
TF85-32-63-55
TORFLEX 8.5F 63CM 55DEG
Used for the percutaneous introduction of various types of
cardiovascular Open, Classified |
DXF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.