PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set
FDA 510(k) clearance K153440 · decided 2016-08-18
Clearance details
- K-number
- K153440
- Device name
- PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-11-27
- Decision date
- 2016-08-18
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Salt Lake Ciy,, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web (P800002/S035) | C.R. Bard, Inc. | 2026-07-15 |
| Covera Vascular Covered Stent (P170042/S015) | C.R. Bard, Inc. | 2026-06-10 |
| Covera Vascular Covered Stent (P170042/S014) | C.R. Bard, Inc. | 2025-12-16 |
| Covera Vascular Covered Stents (P170042/S013) | C.R. Bard, Inc. | 2025-06-26 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S033) | C.R. Bard, Inc. | 2025-03-13 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB (P800002/S032) | C.R. Bard, Inc. | 2025-02-18 |
| Avitene Bulk Flour Cleanroom Expansion (P800002/S031) | C.R. Bard, Inc. | 2024-01-18 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S030) | C.R. Bard, Inc. | 2023-10-04 |