What is FDA product code DQY, what device class and regulation number is it, and list a few recent 510(k) clearances under it with K numbers.

FDA product code DQY is "Catheter, Percutaneous". It is a Class II device under 21 CFR 870.1250 (percutaneous catheter), cleared through the 510(k) pathway by the Cardiovascular panel ^[1].

Classification details ^[1]

• Review division: Coronary and Peripheral Interventional Devices (DHT2C).
• Not GMP-exempt. Not an implant. Not life-sustaining or life-supporting.
• It can go through the 510(k) Third Party Review Program.
• It qualifies for summary malfunction reporting.
• Recognized standards include ISO 10555-1:2023, ISO 10555-4:2023 (balloon dilatation catheters), AAMI TIR42:2021 (particulates), ISO 18193:2021 and ISO 11658:2012.
• FDA guidance: Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings, Labeling Considerations.

Recent 510(k) clearances that list DQY (from FDA clearance-letter search snippets on accessdata.fda.gov)

Most of these recent clearances are neurovascular access catheters. Their primary product code is QJP, and DQY is a secondary code under the same regulation. If you want clearances where DQY is the primary code, you'd need to filter FDA's 510(k) database by product code. This list is a sample, not a complete register.

Approach: The classification comes from FDA's CDRH Product Classification Database. The datasets I can search don't include FDA's 510(k) clearance database, so the clearances come from search snippets of FDA clearance letters on accessdata.fda.gov.

Sources:

• DQY Product Classification, FDA
• K252297
• K254223
• K251372
• K252569
• K252213
• K251044