PowerFlow Apheresis I.V. Port
FDA 510(k) clearance K163001 · decided 2017-04-17
Clearance details
- K-number
- K163001
- Device name
- PowerFlow Apheresis I.V. Port
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-10-28
- Decision date
- 2017-04-17
- Days to decision
- 171 days
- Clearance type
- Traditional
- Product code
- PTD
- Device class
- 2
- Regulation number
- 880.5965
- 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TidalPort-AP Implantable Apheresis Vascular Access Port (K192291) | Norfolk Medical Products, Inc. | 2020-08-20 |
| PowerFlow Implantable Apheresis IV Port (K191143) | C.R. Bard, Inc. | 2019-08-02 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 |
| Covera Vascular Covered Stent (P170042/S012) | C.R. Bard, Inc. | 2023-02-02 |
| Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and Avitene Microfibrillar Collagen Hemostat (MCH) EndoAvit (P800002/S027) | C.R. Bard, Inc. | 2022-04-01 |