510(k) K051395 ยท DQO Catheter, Intravascular, Diagnostic
LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER
| Applicant | Vascular Solutions, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Jun 24, 2005 |
| Received | May 27, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051395
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 20, 2020 | Vascular Solutions, Inc. Langston Dual Lumen Catheter Terminated |
DQO | None listed |
| Oct 20, 2020 | Vascular Solutions, Inc. Langston Dual Lumen Catheter. Terminated |
DQO | None listed |
| Oct 20, 2020 | Vascular Solutions, Inc. Langston Dual Lumen Catheter. Terminated |
DQO | None listed |
| Apr 27, 2020 | Vascular Solutions, Inc. Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies Terminated |
DQO | None listed |
| Jul 3, 2014 | Vascular Solutions, Inc. Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure measurement catheter and for delivery of contrast m Terminated |
DQO | None listed |
| Sep 28, 2010 | Vascular Solutions, Inc. Langston Dual Lumen Catheters, 6F, REF 5540, Sterile EO, RX only, Vascular Solutions, Inc, 6464 Sycamore Court, Minneapolis, MN 55369, 110 cm length, - 0.038" recom guidewire, 1000 psi pressure limit. Terminated |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.