\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR
FDA 510(k) clearance K022536 · decided 2002-10-30
Clearance details
- K-number
- K022536
- Device name
- \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR
- Applicant
- Fresenius Medical Care
- Decision
- Substantially Equivalent
- Date received
- 2002-08-01
- Decision date
- 2002-10-30
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- KOC
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lexington, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A cont recall (Z-1047-2015) | Fresenius Medical Care Holdings, Inc. | 2015-02-03 |
| CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Prote recall (Z-0859-2009) | Fresenius Medical Care North America | 2009-01-23 |
| CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Prote recall (Z-0860-2009) | Fresenius Medical Care North America | 2009-01-23 |