Data / Medical devices / South Africa / Strait Access Technologies Holdings (pty) Ltd
Strait Access Technologies Holdings (pty) Ltd: FDA-registered device maker in Cape Town Western Cape, South Africa, 1 510(k) clearance
Strait Access Technologies Holdings (pty) Ltd is registered with the FDA (registration 3010370269) in Cape Town Western Cape, South Africa. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 25, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010370269
- Address
- 313 Chris Barnard Building UCT Medical School Anzio Road, Observatory, Cape Town Western Cape, South Africa, 7925
- Owner or operator
- Strait Access Technologies Holdings (Pty) Ltd (10094135)
- Roles
- Manufacturer
- First device listed
- November 17, 2025
- Registered through
- 2026
- Brand names listed
- CenterFlow Molding Balloon Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Percutaneous | DQY | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 25, 2025 | K243184 | SAT CenterFlow Molding Balloon Catheter (IN20-00313) | DQY | Substantially Equivalent | Strait Access Technologies Holdings | accessdata.fda.gov |
Compare with other makers
Updated June 25, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.