510(k) K092315 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR
| Applicant | Sorin Group Italia S.R.L., Waltham MA, US |
| Decision | Substantially Equivalent, Aug 12, 2009 |
| Received | Jul 30, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K092315
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.