510(k) K173289 ยท DQO Catheter, Intravascular, Diagnostic
Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Nov 15, 2017 |
| Received | Oct 16, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K173289
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2026 | Cook Incorporated Beacon Tip Centimeter Sizing Catheter
RPN/GPN
NR5.0-35-70-P-10S-0-CSC-20
G31213
NR5.0-35-100-P-10S-0-CSC-20
G31214
NR5.0-35-100-P-10S-PIG-CSC-20
G31216
NR5.0-35-70-P-10S-VCF-CSC-20
G31220
NR5.0-35-100 Open, Classified |
DQO | None listed |
| Jun 16, 2025 | Cook Incorporated Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include different shaft len Open, Classified |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.