510(k) K130896 ยท DWP Dilator, Vessel, Surgical
VASCULAR PROBE, VASCULAR PROBE ES
| Applicant | Synovis Life Technologies, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Apr 24, 2013 |
| Received | Apr 1, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130896
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2024 | Baxter Healthcare Corporation Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specia Open, Classified |
DXC | None listed |
| Jan 5, 2024 | Baxter Healthcare Corporation Baxter Vascular Probe, Product Codes:
a) 7081015: 8CM, 1- 1.5 MM GLOBAL,
b) 7081520: 8CM, 1.5-2 MM GLOBAL,
c) 7082025: 8CM, 2-2.5 MM GLOBAL,
d) 7151015: 15CM, 1-1.5 MM GLOBAL,
e) 7151520 Open, Classified |
DWP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.