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FDA 510(k)

D-3160 SORBENT CARTRIDGE

K-Number: K811170 · 1981-07-31

ApplicantOrganon Teknika Corp.
Decision Date1981-07-31
Product CodeFKT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

D-3160 SORBENT CARTRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1981-07-31 under 510(k) number K811170. 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 D-3160 SORBENT CARTRIDGE?

D-3160 SORBENT CARTRIDGE is a medical device that received FDA 510(k) clearance on 1981-07-31. The listed applicant is Organon Teknika Corp.. The 510(k) number is K811170.

When did D-3160 SORBENT CARTRIDGE receive FDA 510(k) clearance?

D-3160 SORBENT CARTRIDGE received FDA 510(k) clearance on 1981-07-31, under 510(k) number K811170.

Who is the listed applicant for D-3160 SORBENT CARTRIDGE?

The FDA 510(k) record lists Organon Teknika Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for D-3160 SORBENT CARTRIDGE?

The FDA product code for D-3160 SORBENT CARTRIDGE is FKT.

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Other records listing Organon Teknika Corp. 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.

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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.K031099SORB+HISORB+CARTRIDGERenal Solutions, Inc.

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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