510(k) K032417 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
HEPARIN LOCK FLUSH SYRINGE
| Applicant | Am2 Pat, Inc., Raleigh NC, US |
| Decision | Substantially Equivalent, Dec 23, 2003 |
| Received | Aug 5, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032417
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2008 | AM2 PAT INC Sierra Pre-Filled, Heparin Lock Flush Solution USP, 100 units/ml in 0.9% Sodium Chloride 120/Case, Catalog #1003-01, NDC #64054-1003-01, 3 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solut Terminated |
FOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.