510(k) K053440 ยท MJN Catheter, Intravascular Occluding, Temporary
AMPLATZER SIZING BALLOON II
| Applicant | Aga Medical Corp., Plymouth MN, US |
| Decision | Substantially Equivalent, Dec 30, 2005 |
| Received | Dec 9, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053440
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2011 | AGA Medical Corporation AMPLATZER Sizing Balloon II, REF 9-SB-034, Sterile EO, AGA Medical Corporation, 5050 Nathan Lane North, Plymouth, MN 55442.
The AMPLATZER Sizing Balloon II is intended for use in those patients wit Terminated |
MJN | None listed |
| Sep 3, 2008 | AGA Medical Corporation AMPLATZER Sizing Balloon II, REF 9-SB-24. Sterile EO. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. Manufactured in U.S.A. A triple lumen balloon catheter with Terminated |
MJN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.