X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM
FDA premarket approval P020035 · decided 2003-09-30
Approval details
- PMA number
- P020035
- Trade name
- X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM
- Generic name
- Device, hemostasis, vascular
- Applicant
- St. Jude Medical, Inc.
- Date received
- 2002-09-03
- Decision date
- 2003-09-30
- Days to decision
- 392 days
- Decision code
- APWD
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR THE X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM. THE DEVICE IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING SHEATHS LESS THAN OR EQUAL TO 6 FRENCH IN SIZE. THE DEVICE IS INTENDED TO REDUCE THE TIME TO HEMOSTASIS, TIME TO AMBULATION (100 FEET), AND TIME TO DISCHARGEABILITY IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CARDIAC C
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Advisor HD Grid Mapping Catheter, Sensor Enabled (K172393) | St. Jude Medical, Inc. | 2018-04-23 |
| Confirm Rx Insertable Cardiac Monitor (ICM) System (K163407) | St. Jude Medical, Inc. | 2017-09-29 |
| PressureWire X Guidewire (K161171) | St. Jude Medical, Inc. | 2016-08-15 |
| Nanostim Introducer Kit (K161102) | St. Jude Medical, Inc. | 2016-05-19 |
| The Nanostim Introducer Kit (K160716) | St. Jude Medical, Inc. | 2016-04-14 |
| NANOSTIM INTRODUCER KIT (K140793) | St. Jude Medical, Inc. | 2014-12-17 |
| SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) (K133481) | St. Jude Medical, Inc. | 2014-05-28 |
| ENLIGHTN RENAL GUIDE CATHETER (K131592) | St. Jude Medical, Inc. | 2014-01-31 |