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FDA 510(k)

ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1

K-Number: K852309 · 1985-07-26

ApplicantErika, Inc.
Decision Date1985-07-26
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1 is the device name listed in this FDA 510(k) record. The listed applicant is Erika, Inc.. It received FDA 510(k) clearance on 1985-07-26 under 510(k) number K852309. The device is classified under product code FJK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1?

ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1 is a medical device that received FDA 510(k) clearance on 1985-07-26. The listed applicant is Erika, Inc.. The 510(k) number is K852309.

When did ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1 receive FDA 510(k) clearance?

ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1 received FDA 510(k) clearance on 1985-07-26, under 510(k) number K852309.

Who is the listed applicant for ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1?

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

What is the FDA product code for ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1?

The FDA product code for ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1 is FJK.

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Other records listing Erika, 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.

K853134NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8K852310NATURALYTE BICARBONATE CONCENTRATE-DRY PACKK850866TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1LK850865TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1-K850654TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KIDK850655TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2

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Related Devices (Code: FJK)

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.

K252423NovaLine Tubing Set for Hemodialysis (BL 124)Bain Medical Equipment (Guangzhou) Co., Ltd.K251341VITAL Tubing Sets for HemodialysisVital Healthcare Sdn. Bhd.K251442TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)Ningbo Tianyi Medical Appliance Co., Ltd.K243607Moda-flx Hemodialysis System™ Cartridge (102121-001 )Diality, Inc.K213992CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLCK210782Tablo CartridgeOutset Medical, 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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