510(k) K981624 ยท DXC Clamp, Vascular
FLO-THRU
| Applicant | Bio-Vascular, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Aug 4, 1998 |
| Received | May 7, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981624
| 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 Flo-Thru Intraluminal Shunt, Product Codes:
a) Product Code FT12100, 1.00 GLOBAL;
b) Product Code FT12125, 1.25 GLOBAL;
c) Product Code FT12150, 1.50 GLOBAL;
d) Product Code FT12175, 1.75 G Open, Classified |
DXC | None listed |
| Apr 29, 2022 | Baxter Healthcare Corporation Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular
procedures. Used to shunt blood at the anastomosis to provide a temporary blood-free operative field for suturing while allo Terminated |
DXC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.