510(k) K150709 ยท DXF Catheter, Septostomy
ProTrack RF Anchor Wire
| Applicant | Baylis Medical Company, Inc., Mississauga, CA |
| Decision | Substantially Equivalent, Jun 17, 2015 |
| Received | Mar 19, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150709
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.