Aga Medical Corp. - FDA 510(k) Cleared Devices
Recent clearances: AMPLATZER VASCULAR PLUG 4, AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120, AMPLATZER TORQVUE 3 DELIVERY SHEATH, MODEL 9-TV3-08F104, 9-TV3-08F54
14
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Aga Medical Corp. Cardiovascular ✕
14 devices
Cleared
Jun 12, 2012
AMPLATZER VASCULAR PLUG 4
Cardiovascular
183d
Cleared
Feb 05, 2010
AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120,...
Cardiovascular
88d
Cleared
Jul 09, 2009
AMPLATZER TORQVUE 3 DELIVERY SHEATH, MODEL 9-TV3-08F104, 9-TV3-08F54
Cardiovascular
22d
Cleared
May 12, 2009
AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS...
Cardiovascular
193d
Cleared
May 16, 2008
AMPLATZER TORQVUE EXCHANGE SYSTEM
Cardiovascular
39d
Cleared
Apr 18, 2008
AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM
Cardiovascular
31d
Cleared
Nov 02, 2007
AMPLATZER TORQVUE DELIVERY SYSTEM
Cardiovascular
77d
Cleared
Aug 15, 2007
AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022
Cardiovascular
55d
Cleared
Jun 18, 2007
AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010,...
Cardiovascular
56d
Cleared
Feb 28, 2007
AMPLATZER RELIANT CATHETER DELIVERY SYSTEM
Cardiovascular
34d
Cleared
Apr 27, 2006
AMPLATZER NOODLEWIRE GUIDEWIRE
Cardiovascular
163d
Cleared
Dec 30, 2005
AMPLATZER SIZING BALLOON II
Cardiovascular
21d
Cleared
Sep 09, 2003
AMPLATZER VASCULAR PLUG
Cardiovascular
89d
Cleared
Jul 12, 2000
AMPLATZER SIZING BALLOON
Cardiovascular
288d