510(k) K051417 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
6 FR FL POWERHOHN AND POWERLINE CATHETER
| Applicant | C.R. Bard, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Jun 30, 2005 |
| Received | Jun 1, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051417
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2011 | Bard Access Systems Bard PowerLine 6 Fr. Dual-Lumen Polyurethane Catheter with SureCuff Ingrowth Cuff, REF 0700610, Sterile, Contents...1 Each - PTFE Introducer and Dilator, 6.5 FR. x 10 cm..., Assembled in Mexico.
Pro Terminated |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.