PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE
FDA 510(k) clearance K042062 · decided 2004-09-30
Clearance details
- K-number
- K042062
- Device name
- PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE
- Applicant
- Bard Peripheral Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-08-02
- Decision date
- 2004-09-30
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- KCT
- Device class
- 2
- Regulation number
- 880.6850
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Tempe, AZ, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| LifeStent® Vascular Stent Systems (P070014/S066) | Bard Peripheral Vascular, Inc. | 2025-12-16 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S014) | Bard Peripheral Vascular, Inc. | 2025-09-29 |
| FLUENCY PLUS ENDOVASCULAR STENT GRAFT (P130029/S013) | Bard Peripheral Vascular, Inc. | 2025-08-13 |
| Venovo Venous Stent System (P180037/S014) | Bard Peripheral Vascular, Inc. | 2024-12-06 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S013) | Bard Peripheral Vascular, Inc. | 2024-12-06 |
| LifeStent Vascular Stent System (P070014/S065) | Bard Peripheral Vascular, Inc. | 2023-07-27 |
| Fluency Endovascular Stent Graft (P130029/S012) | Bard Peripheral Vascular, Inc. | 2023-02-17 |
| LifeStent 5F Vascular Stent Systems (P070014/S064) | Bard Peripheral Vascular, Inc. | 2023-02-02 |