FDA product code SEQ: Covered Stent Vascular Connector, Hemodialysis Access Circuit
SEQ is the FDA product code for covered stent vascular connector, hemodialysis access circuit. It is a Class III device, reviewed by the Cardiovascular panel. Devices under SEQ reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
The device is intended for suture-less attachment between an arteriovenous (AV) graft to a native vessel or between two native vessels (i.e., lack of suture placement on one or both ends) for the creation of a hemodialysis access site.
Classification
| Field | Value |
|---|---|
| Device name | Covered Stent Vascular Connector, Hemodialysis Access Circuit |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for SEQ devices
openFDA lists no recalls for product code SEQ.
Frequently asked questions
What is FDA product code SEQ?
SEQ is the FDA product code for covered stent vascular connector, hemodialysis access circuit. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is SEQ?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code SEQ
- Run a recall and safety report across every SEQ manufacturer
- Watch product code SEQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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