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FDA 510(k)

SOLCART B

K-Number: K102194 · 2011-04-25

ApplicantB. Braun Avitum AG
Decision Date2011-04-25
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SOLCART B is the device name listed in this FDA 510(k) record. The listed applicant is B. Braun Avitum AG. It received FDA 510(k) clearance on 2011-04-25 under 510(k) number K102194. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLCART B?

SOLCART B is a medical device that received FDA 510(k) clearance on 2011-04-25. The listed applicant is B. Braun Avitum AG. The 510(k) number is K102194.

When did SOLCART B receive FDA 510(k) clearance?

SOLCART B received FDA 510(k) clearance on 2011-04-25, under 510(k) number K102194.

Who is the listed applicant for SOLCART B?

The FDA 510(k) record lists B. Braun Avitum AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOLCART B?

The FDA product code for SOLCART B is KPO.

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Other records listing B. Braun Avitum AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K170574Diacap Pro DialyzerK143482xevonta dialyzerK100334DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811K083460DIALOG WITH ADIMEA OPTION

Related Devices (Code: KPO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260799Nipro Dry Acid Concentrate MixerNipro Technical Solutions, IncoporatedK253462NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)Fresenius Medical Care Renal Therapies Group, LLCK252180Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)Fresenius Medical Care Renal Therapies Group, LLCK243786Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)Fresenius Medical Care Renal Therapies Group, LLCK240920HemoCare Bicarbonate Concentrate Set (BCS)Deka Research and DevelopmentK233950pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)Fresenius Medical Care Renal Therapies Group, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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