BD PowerPiCC Catheter
FDA 510(k) clearance K210264 · decided 2021-07-30
Clearance details
- K-number
- K210264
- Device name
- BD PowerPiCC Catheter
- Applicant
- Bard Access Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-02-01
- Decision date
- 2021-07-30
- Days to decision
- 179 days
- Clearance type
- Traditional
- Product code
- LJS
- Device class
- 2
- Regulation number
- 880.5970
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Salt Lake Ciy,, UT, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Bard Access Systems
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1295108 PowerPICC recall (Z-2666-2026) | Bard Access Systems, Inc. | 2026-07-02 |
| BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 31743 recall (Z-1507-2025) | Bard Access Systems, Inc. | 2025-04-16 |