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FDA 510(k)

2008 HEMODIALYSIS SORBENT SYSTEM

K-Number: K123835 · 2013-02-15

ApplicantRenal Solutions, Inc.
Decision Date2013-02-15
Product CodeFKT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

2008 HEMODIALYSIS SORBENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Renal Solutions, Inc.. It received FDA 510(k) clearance on 2013-02-15 under 510(k) number K123835. The device is classified under product code FKT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 2008 HEMODIALYSIS SORBENT SYSTEM?

2008 HEMODIALYSIS SORBENT SYSTEM is a medical device that received FDA 510(k) clearance on 2013-02-15. The listed applicant is Renal Solutions, Inc.. The 510(k) number is K123835.

When did 2008 HEMODIALYSIS SORBENT SYSTEM receive FDA 510(k) clearance?

2008 HEMODIALYSIS SORBENT SYSTEM received FDA 510(k) clearance on 2013-02-15, under 510(k) number K123835.

Who is the listed applicant for 2008 HEMODIALYSIS SORBENT SYSTEM?

The FDA 510(k) record lists Renal Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 2008 HEMODIALYSIS SORBENT SYSTEM?

The FDA product code for 2008 HEMODIALYSIS SORBENT SYSTEM is FKT.

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Other records listing Renal Solutions, Inc. 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.

K121497VENOFER PUMPK103564VENOFER PUMPK0933622008 HEMODIALYSIS SORBENT SYSTEMK093964VENOFER PUMPK070739ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500K060381ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100

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Related Devices (Code: FKT)

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.

K0933622008 HEMODIALYSIS SORBENT SYSTEMRenal Solutions, Inc.K070739ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500Renal Solutions, Inc.K060381ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100Renal Solutions, Inc.K043574ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000Renal Solutions, Inc.K031099SORB+HISORB+CARTRIDGERenal Solutions, Inc.K954623REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR)Gambro Healthcare

Official Source

View on FDA Database →

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

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