Product code MLV ยท Class 3
Transcatheter Septal Occluder
0510(k)s in 12 months (0 all time)
0recalls in 12 months (15 all time)
0recalls that name a 510(k)
Top companies in MLV
| Company | 510(k)s | Recalls |
|---|---|---|
| W L Gore & Associates, Inc. | 0 | 11 |
| AGA Medical Corporation | 0 | 2 |
| EXP Pharmaceutical Services Corp | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 1, 2023 | W L Gore & Associates, Inc. GORE CARDIOFORM Septal Occluder, REF: GSX0030A Open, Classified |
MLV | None listed |
| Oct 26, 2022 | W L Gore & Associates, Inc. GORE CARDIOFORM ASD Occluder. cardiovascular implant. Open, Classified |
MLV | None listed |
| Sep 2, 2021 | W L Gore & Associates, Inc. REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132648948
*Not distributed within t Open, Classified |
MLV | None listed |
| Sep 2, 2021 | W L Gore & Associates, Inc. REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620128
*Not distributed within Open, Classified |
MLV | None listed |
| Sep 2, 2021 | W L Gore & Associates, Inc. REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620111
*Not distributed within Open, Classified |
MLV | None listed |
| Sep 2, 2021 | W L Gore & Associates, Inc. REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617661
*Not distributed within t Open, Classified |
MLV | None listed |
| Sep 2, 2021 | W L Gore & Associates, Inc. REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617647
*Not distributed within t Open, Classified |
MLV | None listed |
| Sep 2, 2021 | W L Gore & Associates, Inc. REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617630
*Not distributed within t Open, Classified |
MLV | None listed |
| Sep 2, 2021 | W L Gore & Associates, Inc. REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631025
*Not distributed within t Open, Classified |
MLV | None listed |
| Sep 2, 2021 | W L Gore & Associates, Inc. REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631018 Open, Classified |
MLV | None listed |
| Sep 2, 2021 | W L Gore & Associates, Inc. REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631032 Open, Classified |
MLV | None listed |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange 12MM VASCULAR;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number 9-AVP2-012;
EXP (repackager), Aga Medical (OEM)
Transcatheter septal occluder Terminated |
MLV | None listed |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange 10MM VASCULAR;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number 9-AVP2-010;
EXP (repackager), Aga Medical (OEM)
Transcatheter septal occluder Terminated |
MLV | 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 |
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