Company ยท US
AGA Medical Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2012. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
32recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 23, 2012 | K121611 | AMPLATZER TORQVUE FX Aga Medical Corporation | DQY |
| Jun 12, 2012 | K113658 | AMPLATZER VASCULAR PLUG 4 Aga Medical Corp. | KRD |
| Mar 15, 2012 | K120120 | AMPLATZER TORQVUE 45X45 DELIVERY SHEATH AMPLATZER TORQVUE LA1 DELIVERY SHEATH AMPLATZER TORQVUE LA2 SELIVERY SHEATH Aga Medical Corporation | DQY |
| Feb 5, 2010 | K093476 | AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120 Aga Medical Corp. | DQY |
| Jul 9, 2009 | K091793 | AMPLATZER TORQVUE 3 DELIVERY SHEATH, MODEL 9-TV3-08F104, 9-TV3-08F54 Aga Medical Corp. | DQY |
| May 12, 2009 | K083214 | AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100 Aga Medical Corp. | DQY |
| May 16, 2008 | K080994 | AMPLATZER TORQVUE EXCHANGE SYSTEM Aga Medical Corp. | DQY |
| Apr 18, 2008 | K080757 | AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM Aga Medical Corp. | DQY |
| Nov 2, 2007 | K072313 | AMPLATZER TORQVUE DELIVERY SYSTEM Aga Medical Corp. | DQY |
| Aug 15, 2007 | K071699 | AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022 Aga Medical Corp. | KRD |
| Jun 18, 2007 | K071125 | AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016 Aga Medical Corp. | KRD |
| Feb 28, 2007 | K070238 | AMPLATZER RELIANT CATHETER DELIVERY SYSTEM Aga Medical Corp. | DQY |
| Apr 27, 2006 | K053187 | AMPLATZER NOODLEWIRE GUIDEWIRE Aga Medical Corp. | DQX |
| Dec 30, 2005 | K053440 | AMPLATZER SIZING BALLOON II Aga Medical Corp. | MJN |
| Sep 9, 2003 | K031810 | AMPLATZER VASCULAR PLUG Aga Medical Corp. | KRD |
| Jul 12, 2000 | K993248 | AMPLATZER SIZING BALLOON Aga Medical Corp. | MJN |
Latest recalls
| 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 | K053440 |
| Mar 11, 2010 | AGA Medical Corporation AGA Medical Corporation, Amplatzer TorqVue Delivery System 45-degree. REF: 9-1TV10F45/80. Designed to facilitate the introduction of transvenous devices to chambers and coronary vasculature of the Terminated |
DQY | K072313 |
| 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 | K053440 |
| Sep 3, 2008 | AGA Medical Corporation AGA Medical Corporation AMPLATZER Delivery System, 10 French, 45 Degree Angle Curve, 80 Usable Length (cm), REF 9-DEL-10F-45/80. Sterile EO. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Terminated |
None listed | |
| Dec 19, 2006 | AGA Medical Corporation AMPLATZER TorqVue (cardiac septal occluder) Delivery System with Pusher Catheter Order no. 9-TVSP7F-180/80, 9-TVSP8F-180/80, 9-TVSP9F-180/80. [Breakdown of order no. ''9-TVSP-7F-180/80'' is as follow Terminated |
GBK | None listed |
| Dec 19, 2006 | AGA Medical Corporation Amplatzer Cardiac Septal Occluder delivery system Exchange Systems labeled as follows: a) AMPLATZER Exchange System, Order no. 9-EXCH-6F-180/80, 9-EXCH-8F-180/80, 9EXCH-9F-45/80, 9-EXCH-12F-45/80. Terminated |
GBK | None listed |
| Dec 19, 2006 | AGA Medical Corporation Amplatzer Cardiac Septal Occluder Delivery Systems labeled as follows: a) AMPLATZER Delivery System, Order no. 9-DEL-5F-180/60, 9-DEL-6F-45/60, 9-DEL-6F-180/80, 9-DEL-7F-45/60, 9-DEL-7F-45/80, 9-DE Terminated |
GBK | None listed |
| Oct 20, 2006 | AGA Medical Corporation AMPLATZER PFO Occluder. Order No. 9-PFO-025. Device is not PMA approved in the US. 25mm Sterile EO. The AMPLATZER PFO Occluder is a self-expandable, double disc device made from a Nitinol wire m Terminated |
MLV | None listed |
| Oct 20, 2006 | AGA Medical Corporation AMPLATZER PFO Occluder. Order No. 9-PFO-018. Device is not PMA approved in the US. 18mm Sterile EO. The AMPLATZER PFO Occluder is a self-expandable, double disc device made from a Nitinol wire me Terminated |
MLV | None listed |
| Jan 31, 2006 | AGA Medical Corporation AMPLATZER Duct Occluder, Order No. 9-PDA-007, Device Size 12/10mm, Length 8 mm. Sterile EO. Single Use Only. Manufactured by AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 5542 Terminated |
MAE | None listed |
| Jan 31, 2006 | AGA Medical Corporation AMPLATZER Duct Occluder, Order No. 9-PDA-006, Device Size 10/8mm, Length 8 mm. Sterile EO. Single Use Only. Manufactured by AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 Terminated |
MAE | None listed |
| Jan 31, 2006 | AGA Medical Corporation AMPLATZER Duct Occluder, Order No. 9-PDA-005, Device Size 8/6mm, Length 7 mm. Sterile EO. Single Use Only. Manufactured by AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 Terminated |
MAE | None listed |
| Jan 31, 2006 | AGA Medical Corporation AMPLATZER Duct Occluder, Order No. 9-PDA-004, Device Size 6/4mm, Length 7 mm. Sterile EO. Single Use Only. Manufactured by AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 Terminated |
MAE | None listed |
| Jan 31, 2006 | AGA Medical Corporation AMPLATZER Duct Occluder, Order No. 9-PDA-003, Device Size 5/4mm, Length 5 mm. Sterile EO. Single Use Only. Manufactured by AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 Terminated |
MAE | None listed |
| 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 | K031810 |
| Dec 24, 2004 | AGA Medical Corporation AMPLATZER Exchange System 180-degree curve, order no. 9-EXCH-8F-180/80. Product is labeled as Sterile EO.
The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER D Terminated |
GBK | None listed |
| Dec 24, 2004 | AGA Medical Corporation AMPLATZER Exchange System 180-degree curve, order no. 9-EXCH-6F-180/80. Product is labeled as Sterile EO.
The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER D Terminated |
GBK | None listed |
| Dec 24, 2004 | AGA Medical Corporation AMPLATZER Exchange System 45-degree curve, order no. 9-EXCH-12F-45/80. Product is labeled as Sterile EO.
The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER De Terminated |
GBK | None listed |
| Dec 24, 2004 | AGA Medical Corporation AMPLATZER Exchange System 45-degree curve, order no. 9-EXCH-9F-45/80. Product is labeled as Sterile EO.
The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER Del Terminated |
GBK | None listed |
| Dec 24, 2004 | AGA Medical Corporation AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-9F-180/80. Product is labeled as Sterile EO.
Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cabl Terminated |
GBK | None listed |
| Dec 24, 2004 | AGA Medical Corporation AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-8F-180/80. Product is labeled as Sterile EO.
Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cabl Terminated |
GBK | None listed |
| Dec 24, 2004 | AGA Medical Corporation AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-7F-180/80. Product is labeled as Sterile EO.
Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cabl Terminated |
GBK | None listed |
| Dec 24, 2004 | AGA Medical Corporation AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-6F-180/80. Product is labeled as Sterile EO.
Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cabl Terminated |
GBK | None listed |
| Dec 24, 2004 | AGA Medical Corporation AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-5F-180/60. Product is labeled as Sterile EO.
Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cabl Terminated |
GBK | None listed |
| Dec 24, 2004 | AGA Medical Corporation AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-12F-45/80. Product is labeled as Sterile EO.
Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable Terminated |
GBK | None listed |
| Dec 24, 2004 | AGA Medical Corporation AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-10F-45/80. Product is labeled as Sterile EO.
Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable Terminated |
BGK | None listed |
| Dec 24, 2004 | AGA Medical Corporation AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-9F-45/80. Product is labeled as Sterile EO.
Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, Terminated |
GBK | None listed |
| Dec 24, 2004 | AGA Medical Corporation AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-8F-45/80. Product is labeled as Sterile EO.
Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, Terminated |
GBK | None listed |
| Dec 24, 2004 | AGA Medical Corporation AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-8F-45/60. Product is labeled as Sterile EO.
Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, Terminated |
GBK | None listed |
| Dec 24, 2004 | AGA Medical Corporation AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-7F-45/80. Product is labeled as Sterile EO.
Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, Terminated |
GBK | None listed |
| Dec 24, 2004 | AGA Medical Corporation AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-7F-45/60. Product is labeled as Sterile EO.
Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, Terminated |
GBK | None listed |
| Dec 24, 2004 | AGA Medical Corporation Amplatzer Delivery Systems (45-degree curve). order no. 9-DEL-6F-45/60. Product is labeled as Sterile EO.
Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery Terminated |
GBK | None listed |