FDA 510(k) Applications Submitted by AGA MEDICAL CORP.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K093476 |
11/09/2009 |
AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120 |
AGA MEDICAL CORP. |
| K053440 |
12/09/2005 |
AMPLATZER SIZING BALLOON II |
AGA MEDICAL CORP. |
| K070238 |
01/25/2007 |
AMPLATZER RELIANT CATHETER DELIVERY SYSTEM |
AGA MEDICAL CORP. |
| K091793 |
06/17/2009 |
AMPLATZER TORQVUE 3 DELIVERY SHEATH, MODEL 9-TV3-08F104, 9-TV3-08F54 |
AGA MEDICAL CORP. |
| K083214 |
10/31/2008 |
AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100 |
AGA MEDICAL CORP. |
| K993248 |
09/28/1999 |
AMPLATZER SIZING BALLOON |
AGA MEDICAL CORP. |
| K071125 |
04/23/2007 |
AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016 |
AGA MEDICAL CORP. |
| K071699 |
06/21/2007 |
AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022 |
AGA MEDICAL CORP. |
| K080994 |
04/07/2008 |
AMPLATZER TORQVUE EXCHANGE SYSTEM |
AGA MEDICAL CORP. |
| K031810 |
06/12/2003 |
AMPLATZER VASCULAR PLUG |
AGA MEDICAL CORP. |
| K053187 |
11/15/2005 |
AMPLATZER NOODLEWIRE GUIDEWIRE |
AGA MEDICAL CORP. |
| K072313 |
08/17/2007 |
AMPLATZER TORQVUE DELIVERY SYSTEM |
AGA MEDICAL CORP. |
| K080757 |
03/18/2008 |
AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM |
AGA MEDICAL CORP. |
| K113658 |
12/12/2011 |
AMPLATZER VASCULAR PLUG 4 |
AGA MEDICAL CORP. |
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