510(k) K083214 ยท DQY Catheter, Percutaneous
AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100
| Applicant | Aga Medical Corp., Plymouth MN, US |
| Decision | Substantially Equivalent, May 12, 2009 |
| Received | Oct 31, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083214
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.