SURESTAT ARTERIAL CLOSURE SYSTEM
FDA premarket approval P010049/S012 · decided 2004-08-31
Approval details
- PMA number
- P010049
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SURESTAT ARTERIAL CLOSURE SYSTEM
- Generic name
- Device, hemostasis, vascular
- Applicant
- Sub-Q, Inc.
- Date received
- 2004-07-19
- Decision date
- 2004-08-31
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Clemente, CA
- Statement
- APPROVAL TO ADD A POLYSACCHARIDE (CHITOSAN) TO THE HEMOSTATIC PLEDGET FORMULATION AND REQUESTED TO RENAME THE DEVICE FROM THE QUICKSEAL SURESTAT ARTERIAL CLOSURE SYSTEM TO THE SURESTAT ARTERIAL CLOSURE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SURESTAT ARTERIAL CLOSURE SYSTEM AND IS INDICATED FOR "DELIVERY OF T-FOAM FOR EXTRAVASCULAR CLOSURE OF THE FEMORAL ARTERY ACCESS SITES. THE SYSTEM IS INDICATED FOR USE IN REDUCING TIME TO HEMOSTASIS AT FEMORAL ARTERY PUNCTURE S
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| QS DELIVERY SYSTEM (K991254) | Sub-Q, Inc. | 1999-08-23 |
| IRRIGATION SYRINGE KIT (K982435) | Sub-Q, Inc. | 1998-11-06 |