HSA · registration DE0509733Abbott Medical Perclose ProStyle Suture-Mediated Closure and Repair System
- Registration number
- DE0509733
- Model name
- Perclose ProStyle Suture-Mediated Closure and Repair System
- Model identifier
- 12773-02
- Registration date
- September 05, 2024
- Risk class
- Class C
- Product owner
- Abbott Medical
- Registrant / registration holder
- ABBOTT MEDICAL (SINGAPORE), PTE. LTD.
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: • 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. • 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.
- Product owner address
- 3200 Lakeside Drive, Santa Clara, CA 95054, United States
- Registrant address
- 3 FRASER STREET, #23-28, DUO TOWER, Singapore 189352
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.