510(k) K981601 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER
| Applicant | Sorin Group Italia S.R.L., Mirandola, IT |
| Decision | Substantially Equivalent, Jul 28, 1998 |
| Received | May 4, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981601
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.