ADROIT GUIDING CATHETER— 510(k) K131225

Name: FDA 510(k) clearance K131225
Creator: U.S. Food and Drug Administration
Published: 2013-05-29

Substantially Equivalent

Cordis Corp., A Johnson & Johnson Co.

FDA 510(k) clearance K131225 for ADROIT GUIDING CATHETER, Substantially Equivalent on 2013-05-29. Applicant: Cordis Corp., A Johnson & Johnson Co.. Device class: 2.

Clearance details

Applicant: Cordis Corp., A Johnson & Johnson Co.
Product code: Code DQY
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2013-04-30
Decision date: 2013-05-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQY

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K260559 — NHanceIT2026-08-14
K262392 — APRO 35 Swift Catheter2026-08-12
K261766 — CPS Locator 3D Plus Delivery Catheter2026-07-29
K262240 — SSPC NXT Delivery Catheter2026-07-29
K261825 — Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter2026-07-02

More clearances from Cordis Corp., A Johnson & Johnson Co.

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Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K131225

K-number listed on FDA's recall record

Z-0003-2014 — Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.Class II·Terminated·Cordis Corporation·20130812

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131225.

Data sourced from openFDA. This site is unofficial and independent of the FDA.