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FDA 510(k)

SORB+HISORB+CARTRIDGE

K-Number: K031099 · 2003-09-17

ApplicantRenal Solutions, Inc.
Decision Date2003-09-17
Product CodeFKT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SORB+HISORB+CARTRIDGE 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 2003-09-17 under 510(k) number K031099. 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 SORB+HISORB+CARTRIDGE?

SORB+HISORB+CARTRIDGE is a medical device that received FDA 510(k) clearance on 2003-09-17. The listed applicant is Renal Solutions, Inc.. The 510(k) number is K031099.

When did SORB+HISORB+CARTRIDGE receive FDA 510(k) clearance?

SORB+HISORB+CARTRIDGE received FDA 510(k) clearance on 2003-09-17, under 510(k) number K031099.

Who is the listed applicant for SORB+HISORB+CARTRIDGE?

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 SORB+HISORB+CARTRIDGE?

The FDA product code for SORB+HISORB+CARTRIDGE 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.

K1238352008 HEMODIALYSIS SORBENT SYSTEMK121497VENOFER PUMPK103564VENOFER PUMPK0933622008 HEMODIALYSIS SORBENT SYSTEMK093964VENOFER PUMPK070739ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500

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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.

K1238352008 HEMODIALYSIS SORBENT SYSTEMRenal Solutions, Inc.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.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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