SAT CenterFlow Molding Balloon Catheter (IN20-00313)— 510(k) K243184

Name: FDA 510(k) clearance K243184
Creator: U.S. Food and Drug Administration
Published: 2025-06-25

Substantially Equivalent

Strait Access Technologies Holdings

FDA 510(k) clearance K243184 for SAT CenterFlow Molding Balloon Catheter (IN20-00313), Substantially Equivalent on 2025-06-25. Applicant: Strait Access Technologies Holdings. Device class: 2.

Clearance details

Applicant: Strait Access Technologies Holdings
Product code: Code DQY
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2024-09-30
Decision date: 2025-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cape Town, ZA

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

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 →

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