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FDA 510(k)

ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500

K-Number: K070739 · 2007-05-25

ApplicantRenal Solutions, Inc.
Decision Date2007-05-25
Product CodeFKT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 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 2007-05-25 under 510(k) number K070739. 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 ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500?

ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 is a medical device that received FDA 510(k) clearance on 2007-05-25. The listed applicant is Renal Solutions, Inc.. The 510(k) number is K070739.

When did ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 receive FDA 510(k) clearance?

ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 received FDA 510(k) clearance on 2007-05-25, under 510(k) number K070739.

Who is the listed applicant for ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500?

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 ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500?

The FDA product code for ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 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 PUMPK060381ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100

View all 9 devices →

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.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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