Company
EPIX THERAPEUTICS, INC
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OAE | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | 6 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 22, 2021 | EPIX THERAPEUTICS, INC EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT200L, SterileEO, Rx Only, UDI: 00812499030013 Open, Classified |
OAE | None listed |
| Feb 22, 2021 | EPIX THERAPEUTICS, INC EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT100S,SterileEO, Rx Only, UDI: 00812499030006 Open, Classified |
OAE | None listed |
| Feb 22, 2021 | EPIX THERAPEUTICS, INC EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB400L, SterileEO, UDI: 00812499030303 Open, Classified |
OAE | None listed |
| Feb 22, 2021 | EPIX THERAPEUTICS, INC EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB300S, SterileEO, UDI: 00812499030358 Open, Classified |
OAE | None listed |
| Feb 22, 2021 | EPIX THERAPEUTICS, INC EPIX Therapeutics DiamondTemp Unidirectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF: CEDT200L, Sterile EO, UDI: 00812499030259 Open, Classified |
OAE | None listed |
| Feb 22, 2021 | EPIX THERAPEUTICS, INC EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF CEDT100S, SterileEO, UDI 00812499030198 Open, Classified |
OAE | None listed |