QUICK-CLOSE VASCULAR SUTURING SYSTEM (QUICK-CLOSE SYSTEM)
FDA premarket approval P080029 · decided 2010-04-08
Approval details
- PMA number
- P080029
- Trade name
- QUICK-CLOSE VASCULAR SUTURING SYSTEM (QUICK-CLOSE SYSTEM)
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cardiva Medical, Inc.
- Date received
- 2008-12-05
- Decision date
- 2010-04-08
- Days to decision
- 489 days
- Decision code
- APWD
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- 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 I
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CATALYST II AND III (K130124) | Cardiva Medical, Inc. | 2013-03-14 |
| CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE (K082930) | Cardiva Medical, Inc. | 2009-02-13 |
| BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM (K072297) | Cardiva Medical, Inc. | 2007-09-12 |
| BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 58L (K070485) | Cardiva Medical, Inc. | 2007-03-22 |
| BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM (K051817) | Cardiva Medical, Inc. | 2006-12-06 |
| BOOMERANG WIRE (K061075) | Cardiva Medical, Inc. | 2006-09-01 |
| VASOSTASIS VASCULAR CLOSURE SYSTEM (K041486) | Cardiva Medical, Inc. | 2004-10-22 |