FRSENIUS PD IQCARD CYCLER
FDA 510(k) clearance K002892 · decided 2001-04-05
Clearance details
- K-number
- K002892
- Device name
- FRSENIUS PD IQCARD CYCLER
- Applicant
- Fresenius Medical Care North America
- Decision
- Substantially Equivalent
- Date received
- 2000-09-15
- Decision date
- 2001-04-05
- Days to decision
- 202 days
- Clearance type
- Traditional
- Product code
- FKX
- 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 |
|---|---|---|
| Newton IQ 4 Lead Cycler Set with stay-safe patient connectors, used for acute and chronic recall (Z-0834-06) | Fresenius Medical Care North America | 2006-05-03 |