Device, Hemostasis, Vascular
Basic Information
- Device Name
- Device, Hemostasis, Vascular
- Trade Name
- QUICK-CLOSE VASCULAR SUTURING SYSTEM (QUICK-CLOSE SYSTEM)
- PMA Number
- P080029
- Device Class
- FDA Class 3
- Product Code
- MGB
- Generic Name
- Device, hemostasis, vascular
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- April 8, 2010
- Date Received
- December 5, 2008
- Expedited Review
- N
- Docket Number
- 10M-0220
Advisory Committee Statement
APPROVAL FOR THE QUICK-CLOSE VASCULAR SUTURING SYSTEM. THIS DEVICE IS INDICATED AS FOLLOWS:THE QUICK-CLOSE VASCULAR SUTURING SYSTEM IS INDICATED TO CLOSE FEMORAL ARTERY ACCESSSITES AND TO REDUCE TIME-TO-HEMOSTASIS AND TIME-TO-AMBULATION IN PATIENTS WHO HAVEUNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR PROCEDURES UTILIZING A 5, 6, 7, OR 8FRENCH PROCEDURAL SHEATH. ADDITIONALLY, THE QUICK-CLOSE VASCULAR SUTURING SYSTEM IS INDICATED TO REDUCE TIME-TO-HEMOSTASIS IN PATIENTS WHO HAVE UNDERGONE INTERVENTIONALENDOVASCULAR PROCEDURES UTILIZING A 5, 6, 7, OR 8 FRENCH PROCEDURAL SHEATH, WHO HAVERECEIVED INTRAPROCEDURAL GLYCOPROTEIN IIB/IIIA INHIBITOR THERAPY.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MGB | Device, Hemostasis, Vascular | FDA class 3 | Unknown |