510(k) K051067 ยท MJN Catheter, Intravascular Occluding, Temporary
PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)
| Applicant | LeMaitre Vascular, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, May 27, 2005 |
| Received | Apr 26, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051067
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 19, 2011 | Lemaitre Vascular, Inc. LeMaitre 9F Pruitt F3 Outlying Carotid Shunt with T-port
The Pruitt F3 Carotid Shunt (the Shunt) is a multi-lumen device with balloons at both the distal (internal carotid) and proximal (common carot Terminated |
MJN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.