Device recall
Z-0655-2013: FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain…
FDA device recall · Class II · Concentric Medical Inc
Key facts
| Recall number (Z-number) | Z-0655-2013 |
|---|---|
| Recall event | 63938 |
| Product | FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA. FlowGate" Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters with a radiopaque marker on the distal end and a bifurcated luer… |
| Product code | DQY |
| Recalling firm | Concentric Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 5, 2013 |
| 510(k) numbers | K122581 |
| FEI number | 3003271051 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database