FDA product code LQQ: Columns, Immunoadsorption In Extracorporeal Systems

LQQ is the FDA product code for columns, immunoadsorption in extracorporeal systems. It is a Class III device, reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under LQQ. The average 510(k) review took 245 days (median 245). FDA has posted 1 recall for LQQ devices.

Classification

Top LQQ applicants

Most recent LQQ clearances

Recalls for LQQ devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2003-07-11.

Frequently asked questions

What is FDA product code LQQ?

LQQ is the FDA product code for columns, immunoadsorption in extracorporeal systems. It is a Class III device, reviewed by the Gastroenterology and Urology panel.

What device class is LQQ?

Class III. Typical premarket route: PMA.

How long does a 510(k) take for product code LQQ?

Across 1 cleared submissions the average was 245 days from receipt to decision (median 245).

Which companies have the most LQQ clearances?

Extracorporeal Medical Specialities, Inc. (1).

Have LQQ devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2003-07-11.

Next steps

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