FDA applicant
Strait Access Technologies Holdings
FDA records 1 decision for Strait Access Technologies Holdings (Cape Town, ZA) in 2025: 1 510(k) clearance. All are in product code DQY (Catheter, Percutaneous). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Strait Access Technologies Holdings’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like Strait Access Technologies Holdings’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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