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Abbott Medical Perclose ProStyle Suture-Mediated Closure and Repair System - HSA Registration DE0509733

Access comprehensive regulatory information for Abbott Medical Perclose ProStyle Suture-Mediated Closure and Repair System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509733 and owned by Abbott Medical. The device was registered on September 05, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS C
DE0509733
Abbott Medical Perclose ProStyle Suture-Mediated Closure and Repair System
HSA Registration Number: DE0509733
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Product Description

The Perclose ProStyle SMCR System is intended to restore normal blood vessel hemostasis. It is indicated for the percutaneous delivery of suture for closing the common femoral artery and vein access site of patients who have undergone diagnostic or interventional catheterization procedures: โ€ข For access sites in the common femoral artery using 5F to 21F sheaths. For sheath sizes greater than 8F, at least two devices and the pre-close technique are required. โ€ข For access sites in the common femoral vein using 5F to 24F sheaths. For sheath sizes greater than 8F, at least one device and the pre-close technique is required.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0509733
Registration Date
September 05, 2024
Retention Due Date
September 04, 2025
Product Owner
Short Name
Abbott Medical
Address
3200 Lakeside Drive, Santa Clara, CA 95054, UNITED STATES
Registrant
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model Information
Model Name(s)
Perclose ProStyle Suture-Mediated Closure and Repair System
Model Identifier(s)
12773-02