FDA product code NIK: Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

NIK is the FDA product code for defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d). It is a Class III device, reviewed by the Cardiovascular panel. Devices under NIK reach the market by PMA; FDA lists no cleared 510(k)s for it. 11 PMA applications cite this product code. FDA has posted 153 recalls for NIK devices, 75 initiated in the last five years.

Definition

These devices will be indicated for patients needing an ICD who also have moderate to severe heart failure and are indicated for cardiac resynchronization therapy.

Classification

Recalls for NIK devices

153 product recalls in 42 recall events; 75 initiated in the last five years and 81 still open. Most recent: 2024-04-16.

Frequently asked questions

What is FDA product code NIK?

NIK is the FDA product code for defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d). It is a Class III device, reviewed by the Cardiovascular panel.

What device class is NIK?

Class III. Typical premarket route: PMA.

Have NIK devices been recalled?

Yes: 153 product recalls across 42 recall events; the most recent began 2024-04-16.

Next steps

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