Product code DQY: 510(k) clearances and predicates
Product code DQY covers CrossFAST Integrated Microcatheter Advanced Delivery System. FDA lists 896 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
896 clearances on file under product code DQY. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 18 |
| 2023 | 18 |
| 2024 | 16 |
| 2025 | 21 |
| 2026 so far | 11 |
Recent clearances
Newest DQY clearances in the FDA index, with applicant and decision date:
- K262817, CrossFAST Integrated Microcatheter Advanced Delivery System, applicant Vantis Vascular, Inc., decided 2026-09-18. FDA record
- K260559, NHanceIT, applicant IMDS Operation B.V., decided 2026-08-14. FDA record
- K262392, APRO 35 Swift Catheter, applicant Alembic, LLC, decided 2026-08-12. FDA record
- K262240, SSPC NXT Delivery Catheter, applicant CenterPoint Systems, LLC, decided 2026-07-29. FDA record
- K261766, CPS Locator 3D Plus Delivery Catheter, applicant CenterPoint Systems, LLC, decided 2026-07-29. FDA record
- K261825, Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter, applicant Abbott, decided 2026-07-02. FDA record
- K261631, Amplatzer TorqVue Exchange System, applicant Abbott Medical, decided 2026-06-17. FDA record
- K260289, Perfect-O Ostial Positioning Catheter, applicant Balosmark, Inc., decided 2026-06-05. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include NHanceIT, APRO 35 Swift Catheter. Watch new DQY clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code DQY?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent DQY clearances include CrossFAST Integrated Microcatheter Advanced Delivery System.
How many 510(k) clearances use product code DQY?
896 at the time this page was generated, from openFDA records.
How do I find a predicate device under DQY?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new DQY clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.