# Aga Medical Corp.

- Location (FDA's records): Plymouth, MN
- FDA decisions: 16 (2000–2012): 16 510(k) clearances
- Names in FDA's records: Aga Medical Corp. (14); Aga Medical Corporation (2)
- Product codes: DQY (9), KRD (4), MJN (2), DQX (1)
- Predicates its devices cite: 24 (14 its own); citations of its devices by later devices: 33 (14 its own)
- Recalls linked to its devices: 5 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Target Therapeutics: 4 (https://510kreport.com/company/target-therapeutics)
- Medtronic Inc. Cardiac Rhythm Management: 2 (https://510kreport.com/company/medtronic-cardiac-rhythm-management)
- Cook, Inc.: 2 (https://510kreport.com/company/cook)
- NuMED, Inc.: 1 (https://510kreport.com/company/numed)
- Cordis Corp.: 1 (https://510kreport.com/company/cordis)

## Firms that cite its devices most
- Aga Medical COrporation (Wholly Owned by St. Jude Medical CO: 2 (https://510kreport.com/company/aga-medical-wholly-owned-by-st-jude-medical)
- Artventive Medical Group, Inc.: 2 (https://510kreport.com/company/artventive-medical-group)
- Nuvascular, Inc.: 2 (https://510kreport.com/company/nuvascular)
- Abbott Medical: 2 (https://510kreport.com/company/abbott-medical)
- St Jude Medical: 2 (https://510kreport.com/company/st-jude-medical)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)
- Reverse Medical Corporation: 1 (https://510kreport.com/company/reverse-medical)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)

## Its most-cited devices
- K072313: Amplatzer Torqvue Delivery System (2007), cited by 11
- K083214: Amplatzer Torqvue  45DEGREEX45DEGREE Delivery Sheath, Models 9-TV45X45-09F-100, 9-TV45X45-10F-100 (2009), cited by 4
- K113658: Amplatzer Vascular Plug 4 (2012), cited by 4
- K031810: Amplatzer Vascular Plug (2003), cited by 4
- K071125: Amplatzer Vascular Plug II Models: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016 (2007), cited by 3
- K080757: Amplatzer Torqvue Low Profile Delivery System (2008), cited by 2

## Recent decisions
- K121611: Amplatzer Torqvue FX (Aug 23, 2012)
- K113658: Amplatzer Vascular Plug 4 (Jun 12, 2012)
- K120120: Amplatzer Torqvue 45X45 Delivery Sheath Amplatzer Torqvue LA1 Delivery Sheath Amplatzer Torqvue LA2 Selivery Sheath (Mar 15, 2012)
- K093476: Amplatzer Torq Vue 2 Delivery Sheath Model 9-TV2-05F120, Model 9-TV2-06F120, Modeltv-2-07F120 (Feb 5, 2010)
- K091793: Amplatzer Torqvue 3 Delivery Sheath, Model 9-TV3-08F104, 9-TV3-08F54 (Jul 9, 2009)
- K083214: Amplatzer Torqvue  45DEGREEX45DEGREE Delivery Sheath, Models 9-TV45X45-09F-100, 9-TV45X45-10F-100 (May 12, 2009)
- K080994: Amplatzer Torqvue Exchange System (May 16, 2008)
- K080757: Amplatzer Torqvue Low Profile Delivery System (Apr 18, 2008)

Source page: https://510kreport.com/company/aga-medical