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FDA 510(k)

ERIKA NEGATIVE PRESSURE VENOUS BL SETS

K-Number: K792054 · 1979-12-06

ApplicantErika, Inc.
Decision Date1979-12-06
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ERIKA NEGATIVE PRESSURE VENOUS BL SETS is the device name listed in this FDA 510(k) record. The listed applicant is Erika, Inc.. It received FDA 510(k) clearance on 1979-12-06 under 510(k) number K792054. 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 NEGATIVE PRESSURE VENOUS BL SETS?

ERIKA NEGATIVE PRESSURE VENOUS BL SETS is a medical device that received FDA 510(k) clearance on 1979-12-06. The listed applicant is Erika, Inc.. The 510(k) number is K792054.

When did ERIKA NEGATIVE PRESSURE VENOUS BL SETS receive FDA 510(k) clearance?

ERIKA NEGATIVE PRESSURE VENOUS BL SETS received FDA 510(k) clearance on 1979-12-06, under 510(k) number K792054.

Who is the listed applicant for ERIKA NEGATIVE PRESSURE VENOUS BL SETS?

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 NEGATIVE PRESSURE VENOUS BL SETS?

The FDA product code for ERIKA NEGATIVE PRESSURE VENOUS BL SETS 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 PACKK852309ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1K850866TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1LK850865TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1-K850654TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID

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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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