FDA product code SCZ: Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures

SCZ is the FDA product code for percutaneous catheter for cutting or splitting heart valve leaflets concomitant to transcatheter valve procedures. It is a Class II device, regulated under 21 CFR 870.1254 and reviewed by the Cardiovascular panel. Devices under SCZ reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it. FDA has posted 1 recall for SCZ devices, 1 initiated in the last five years.

Definition

The device is a single use percutaneous catheter system intended for mechanically splitting aortic valve leaflets that may prevent coronary artery ostia obstruction during planned transcatheter valve procedures.

Classification

Recalls for SCZ devices

1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-07-06.

Frequently asked questions

What is FDA product code SCZ?

SCZ is the FDA product code for percutaneous catheter for cutting or splitting heart valve leaflets concomitant to transcatheter valve procedures. It is a Class II device, regulated under 21 CFR 870.1254 and reviewed by the Cardiovascular panel.

What device class is SCZ?

Class II, regulation 21 CFR 870.1254. Typical premarket route: 510(k).

Have SCZ devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2026-07-06.

Next steps

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