FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR
FDA 510(k) clearance K022412 · decided 2003-03-05
Clearance details
- K-number
- K022412
- Device name
- FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR
- Applicant
- Fresenius Medical Care North America
- Decision
- Substantially Equivalent
- Date received
- 2002-07-24
- Decision date
- 2003-03-05
- Days to decision
- 224 days
- Clearance type
- Traditional
- Product code
- KDJ
- Device class
- 2
- Regulation number
- 876.5630
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lexington, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Fresenius Medical Care North America
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 |
|---|---|---|
| stay-safe /Safe Lock Catheter Ext. 12 in recall (Z-1323-2024) | Fresenius Medical Care Holdings, Inc. | 2024-03-26 |
| stay-safe /Luer Lock Adapter 4 in recall (Z-1324-2024) | Fresenius Medical Care Holdings, Inc. | 2024-03-26 |
| stay-safe /Luer Lock Catheter Ext. 12 in recall (Z-1325-2024) | Fresenius Medical Care Holdings, Inc. | 2024-03-26 |
| stay-safe /Luer Lock Catheter Ext. 18 in recall (Z-1326-2024) | Fresenius Medical Care Holdings, Inc. | 2024-03-26 |
| stay-safe /Luer Catheter Ext. 6 in recall (Z-1327-2024) | Fresenius Medical Care Holdings, Inc. | 2024-03-26 |