FDA product code DSQ: Ventricular (Assist) Bypass

DSQ is the FDA product code for ventricular (assist) bypass. It is a Class III device, reviewed by the Cardiovascular panel. Devices under DSQ reach the market by PMA; FDA lists no cleared 510(k)s for it. 9 PMA applications cite this product code. FDA has posted 131 recalls for DSQ devices, 52 initiated in the last five years.

Definition

Approved pma: P870072

Classification

Recalls for DSQ devices

131 product recalls in 77 recall events; 52 initiated in the last five years and 91 still open. Most recent: 2026-05-13.

Frequently asked questions

What is FDA product code DSQ?

DSQ is the FDA product code for ventricular (assist) bypass. It is a Class III device, reviewed by the Cardiovascular panel.

What device class is DSQ?

Class III. Typical premarket route: PMA.

Have DSQ devices been recalled?

Yes: 131 product recalls across 77 recall events; the most recent began 2026-05-13.

Next steps

• Run an FDA pathway report with predicate devices for product code DSQ
• Run a recall and safety report across every DSQ manufacturer
• Watch product code DSQ 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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