510(k) K031810 ยท KRD Device, Vascular, For Promoting Embolization
AMPLATZER VASCULAR PLUG
| Applicant | Aga Medical Corp., Plymouth MN, US |
| Decision | Substantially Equivalent, Sep 9, 2003 |
| Received | Jun 12, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031810
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 5, 2005 | AGA Medical Corporation AMPLATZER Vascular Plug, Manufactured by AGA Medical Corporation , 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. Sterile EO. Single Use Only. Rx Only. Do not use open or damaged packages Terminated |
KRD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.