Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Aga Medical Corp. · Predicate Candidate Screening

14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

77 daysmedian FDA review time

193 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K113658	AMPLATZER VASCULAR PLUG 4	Aga Medical Corp.	2012-06-12	183	0
K093476	AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MOD	Aga Medical Corp.	2010-02-05	88	0
K091793	AMPLATZER TORQVUE 3 DELIVERY SHEATH, MODEL 9-TV3-08F104, 9-T	Aga Medical Corp.	2009-07-09	22	0
K083214	AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS	Aga Medical Corp.	2009-05-12	193	0
K080994	AMPLATZER TORQVUE EXCHANGE SYSTEM	Aga Medical Corp.	2008-05-16	39	0
K080757	AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM	Aga Medical Corp.	2008-04-18	31	0
K072313	AMPLATZER TORQVUE DELIVERY SYSTEM	Aga Medical Corp.	2007-11-02	77	1
K071699	AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-	Aga Medical Corp.	2007-08-15	55	0
K071125	AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-	Aga Medical Corp.	2007-06-18	56	0
K070238	AMPLATZER RELIANT CATHETER DELIVERY SYSTEM	Aga Medical Corp.	2007-02-28	34	0
K053187	AMPLATZER NOODLEWIRE GUIDEWIRE	Aga Medical Corp.	2006-04-27	163	0
K053440	AMPLATZER SIZING BALLOON II	Aga Medical Corp.	2005-12-30	21	2
K031810	AMPLATZER VASCULAR PLUG	Aga Medical Corp.	2003-09-09	89	1
K993248	AMPLATZER SIZING BALLOON	Aga Medical Corp.	2000-07-12	288	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda