Centerline Biomedical, Inc.
Dispositifs autorisés FDA 510(k) et PMA — 6 produits
Publicité
Nombre total de dispositifs6
Catégories0
Dernière décision de la FDA
| Type | Numéro | Nom du dispositif | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K254089 | IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035) | DQK | 2026-02-17 | Voir |
| 510(k) | K243842 | Intra-Operative Positioning System (IOPS®) | DQK | 2025-03-06 | Voir |
| 510(k) | K242133 | Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle) | DQK | 2024-10-11 | Voir |
| 510(k) | K241243 | Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters) | DQK | 2024-07-24 | Voir |
| 510(k) | K230309 | Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1) | DQK | 2023-06-21 | Voir |
| 510(k) | K190106 | Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle | DQK | 2019-06-24 | Voir |
Aucun dispositif correspondant.