Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010370269

FEI Number

3010370269

Entity Name

STRAIT ACCESS TECHNOLOGIES HOLDINGS (PTY) LTD

City/State/Country

Cape Town Western Cape, ZA

Establishment Address

313 Chris Barnard Building UCT Medical School, Anzio Road, Observatory, Cape Town Western Cape 7925, ZA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Strait Access Technologies Holdings (Pty) Ltd (Owner Number: 10094135)

Owner / Operator Contact Address

313 Chris Barnard Building UCT Medical School, Anzio Road, Observatory, Cape Town, ZA-WC 7925, ZA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243184

PMA Number

N/A

All Registered Proprietary Names

CenterFlow Molding Balloon Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-11-17

Official Correspondent

Veruscha Goodheart

US Agent Details

Stephan Toupin Business: DAWA Medical LLC Email: stoupin@dawamedical.com Phone: (305) 5999773

Related Public Records

Same Entity

Strait Access Technologies Holdings (Pty) Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24
K982883	Medtronics Interventional Vascular	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	1998-09-04
K132420	Reflow Medical	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	2013-09-19
K082339	Endocross, Ltd.	ENABLER-P SUPPORT CATHETER	2008-11-20
K210009	CenterPoint Systems, LLC	Guiding Catheter	2021-11-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04	Bard Peripheral Vascular	2	Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

Similar Registrations

Registration Number	Establishment Name	Location
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3031768596	PIRAEUS MEDICAL, INC.	Maple Grove, MN, US
3013134719	HEXACATH	Rueil Malmaison Ile-de-France, FR
3011142981	Rontis Hellas S.A.	Larisa Thessalia, GR
3031311812	TORO NEUROVASCULAR, INC.	Irvine, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010370269. Last updated year: 2026. Please use registration number 3010370269 when referencing this establishment in official correspondence.