Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set
FDA 510(k) clearance K173651 · decided 2018-02-14
Clearance details
- K-number
- K173651
- Device name
- Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC
- Decision
- Substantially Equivalent
- Date received
- 2017-11-28
- Decision date
- 2018-02-14
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- KDJ
- Device class
- 2
- Regulation number
- 876.5630
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.