VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER AND SKYWAY SUPPORT CATHETER
FDA 510(k) clearance K060327 · decided 2006-04-12
Clearance details
- K-number
- K060327
- Device name
- VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER AND SKYWAY SUPPORT CATHETER
- Applicant
- Vascular Solutions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-02-09
- Decision date
- 2006-04-12
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with Ethylene recall (Z-0054-2017) | Vascular Solutions, Inc. | 2016-10-20 |
| Twin-Pass Dual Access Catheter , REF 5200, sterilized with Ethylene Oxide, RX Only, Non-Py recall (Z-1712-2009) | Vascular Solutions, Inc. | 2009-08-21 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Duett Sealing Device (D-Stat Flowable) (P990037/S036) | Vascular Solutions, Inc. | 2022-11-04 |
| Duett Sealing Device (P990037/S035) | Vascular Solutions, Inc. | 2021-07-13 |
| D-Stat Flowable hemostat (P990037/S034) | Vascular Solutions, Inc. | 2016-10-05 |
| D-STAT FLOWABLE HEMOSTAT (P990037/S032) | Vascular Solutions, Inc. | 2016-02-25 |
| VASCULAR SOLUTIONS DUETT SEALING DEVICE (P990037/S031) | Vascular Solutions, Inc. | 2010-09-15 |
| VASCULAR SOLUTIONS DUETT SEALING DEVICE (P990037/S030) | Vascular Solutions, Inc. | 2010-05-07 |
| D-STAT FLOWABLE HEMOSTAT (P990037/S029) | Vascular Solutions, Inc. | 2009-12-02 |
| DUETT PRO SEALING DEVICE, MODEL 1010 (P990037/S028) | Vascular Solutions, Inc. | 2008-12-17 |