Aga Medical Corp.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under 2 spellings of the applicant name “Aga Medical Corp.” (first 2000, latest 2012), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 68 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Abbott, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 83 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQY | Catheter, Percutaneous | 9 | 9 |
| KRD | Device, Vascular, For Promoting Embolization | 4 | 4 |
| MJN | Catheter, Intravascular Occluding, Temporary | 2 | 2 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
Review panels
- Cardiovascular (16)
Most recent Aga Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K121611 | AMPLATZER TORQVUE FX | DQY | 2012-08-23 | 83 |
| K113658 | AMPLATZER VASCULAR PLUG 4 | KRD | 2012-06-12 | 183 |
| K120120 | AMPLATZER TORQVUE 45X45 DELIVERY SHEATH AMPLATZER TORQVUE LA1 DELIVERY SHEATH AMPLATZER TORQVUE LA2 SELIVERY SHEATH | DQY | 2012-03-15 | 58 |
| K093476 | AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120 | DQY | 2010-02-05 | 88 |
| K091793 | AMPLATZER TORQVUE 3 DELIVERY SHEATH, MODEL 9-TV3-08F104, 9-TV3-08F54 | DQY | 2009-07-09 | 22 |
| K083214 | AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100 | DQY | 2009-05-12 | 193 |
| K080994 | AMPLATZER TORQVUE EXCHANGE SYSTEM | DQY | 2008-05-16 | 39 |
| K080757 | AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM | DQY | 2008-04-18 | 31 |
| K072313 | AMPLATZER TORQVUE DELIVERY SYSTEM | DQY | 2007-11-02 | 77 |
| K071699 | AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022 | KRD | 2007-08-15 | 55 |
6 earlier clearances. See the full list in Caduvo.
Recalls
32 product recalls in 8 recall events; 0 initiated in the last five years. Most recent: 2010-12-17.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Aga Medical Corp. (14)
- Aga Medical Corporation (2)
Frequently asked questions
How many FDA 510(k) clearances are listed under Aga Medical Corp.?
FDA lists 16 510(k) clearances under 2 spellings of the applicant name “Aga Medical Corp.” (first 2000, latest 2012), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Aga Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aga Medical Corp. is 68 days.
Which FDA product codes appear under Aga Medical Corp.?
The most frequent FDA product codes under this applicant name are DQY (Catheter, Percutaneous, 9); KRD (Device, Vascular, For Promoting Embolization, 4); MJN (Catheter, Intravascular Occluding, Temporary, 2).
Next steps
- See all 16 Aga Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code DQY, Aga Medical Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.