510(k) Report

FDA applicant

Aga Medical Corp.

Plymouth, MN16 decisions2000–20125 recalls

FDA records 16 decisions for Aga Medical Corp. (Plymouth, MN) from 2000 to 2012: 16 510(k) clearances. Most are in product codes DQY (Catheter, Percutaneous) and KRD (Device, Vascular, For Promoting Embolization). Its devices cite 24 predicates, 14 of them its own earlier devices. 5 recalls are linked to its devices, 1 Class I.

FDA’s records also spell it “Aga Medical Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Aga Medical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2012

2007: 42008: 22009: 22010: 12012: 3
2007high 4 (2007) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2013

2008: 12009: 12010: 12013: 1, 1 Class I
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Aga Medical Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Aga Medical Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DQYCatheter, Percutaneous9decisions
  • KRDDevice, Vascular, For Promoting Embolization4decisions
  • MJNCatheter, Intravascular Occluding, Temporary2decisions
  • DQXWire, Guide, Catheter1decision

Whose devices does it build on?

Its devices cite 24 predicates; 14 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 33 times; 14 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K072313Amplatzer Torqvue Delivery SystemAga Medical Corp. · 200711cite it
  • K083214Amplatzer Torqvue 45DEGREEX45DEGREE Delivery Sheath, Models 9-TV45X45-09F-100, 9-TV45X45-10F-100Aga Medical Corp. · 20094cite it
  • K113658Amplatzer Vascular Plug 4Aga Medical Corp. · 20124cite it
  • K031810Amplatzer Vascular PlugAga Medical Corp. · 20034cite it
  • K071125Amplatzer Vascular Plug II Models: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016Aga Medical Corp. · 20073cite it
  • K080757Amplatzer Torqvue Low Profile Delivery SystemAga Medical Corp. · 20082cite it

What has FDA decided for it lately?

  • K121611Amplatzer Torqvue FXAga Medical Corporation · 20121 Class I recall
  • K113658Amplatzer Vascular Plug 4Aga Medical Corp. · 2012
  • K120120Amplatzer Torqvue 45X45 Delivery Sheath Amplatzer Torqvue LA1 Delivery Sheath Amplatzer Torqvue LA2 Selivery…Aga Medical Corporation · 2012
  • K093476Amplatzer Torq Vue 2 Delivery Sheath Model 9-TV2-05F120, Model 9-TV2-06F120, Modeltv-2-07F120Aga Medical Corp. · 2010
  • K091793Amplatzer Torqvue 3 Delivery Sheath, Model 9-TV3-08F104, 9-TV3-08F54Aga Medical Corp. · 2009
  • K083214Amplatzer Torqvue 45DEGREEX45DEGREE Delivery Sheath, Models 9-TV45X45-09F-100, 9-TV45X45-10F-100Aga Medical Corp. · 2009
  • K080994Amplatzer Torqvue Exchange SystemAga Medical Corp. · 2008
  • K080757Amplatzer Torqvue Low Profile Delivery SystemAga Medical Corp. · 2008

All 14 as Aga Medical Corp. →All 2 as Aga Medical Corporation →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K121611St. Jude Medical, AGA Medical corporation, AMPLATZER TorqVue FX Delivery System. Model…Jan 18, 2013Class I
  • K053440AMPLATZER Sizing Balloon II, REF 9-SB-034, Sterile EO, AGA Medical Corporation, 5050…Dec 17, 2010
  • K072313AGA Medical Corporation, Amplatzer TorqVue Delivery System 45-degree. REF…Dec 18, 2009
  • K053440AMPLATZER Sizing Balloon II, REF 9-SB-24. Sterile EO. AGA Medical Corporation, 682…Apr 25, 2008
  • K031810AMPLATZER Vascular Plug, Manufactured by AGA Medical Corporation , 682 Mendelssohn…Sep 1, 2005