Atlas FDA

bibag

FDA 510(k) clearance K162716 · decided 2017-05-18

Clearance details

K-number
K162716
Device name
bibag
Applicant
Fresenius Medical Care Renal Therapies Group, LLC
Decision
Substantially Equivalent
Date received
2016-09-29
Decision date
2017-05-18
Days to decision
231 days
Clearance type
Traditional
Product code
KPO
Device class
2
Regulation number
876.5820
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Waltham, MA, US
Third-party review
No
Expedited review
No

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pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) (K233950)Fresenius Medical Care Renal Therapies Group, LLC2024-05-10
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pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 (K233159)Fresenius Medical Care Renal Therapies Group, LLC2023-12-01
Citric Complete Liquid Citric Acid Concentrate (K223431)Nipro Renal Solutions USA, Corp.2023-08-04
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Recalls involving this device

No recalls on record reference this clearance.