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FDA 510(k)

BLOOD LINE SETS FOR HEMOFILTRATION

K-Number: K830677 · 1983-04-12

ApplicantGambro, Inc.
Decision Date1983-04-12
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BLOOD LINE SETS FOR HEMOFILTRATION is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1983-04-12 under 510(k) number K830677. 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 BLOOD LINE SETS FOR HEMOFILTRATION?

BLOOD LINE SETS FOR HEMOFILTRATION is a medical device that received FDA 510(k) clearance on 1983-04-12. The listed applicant is Gambro, Inc.. The 510(k) number is K830677.

When did BLOOD LINE SETS FOR HEMOFILTRATION receive FDA 510(k) clearance?

BLOOD LINE SETS FOR HEMOFILTRATION received FDA 510(k) clearance on 1983-04-12, under 510(k) number K830677.

Who is the listed applicant for BLOOD LINE SETS FOR HEMOFILTRATION?

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

What is the FDA product code for BLOOD LINE SETS FOR HEMOFILTRATION?

The FDA product code for BLOOD LINE SETS FOR HEMOFILTRATION is FJK.

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Other records listing Gambro, 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.

K083158EXALIS, SOFTWARE VERSION 1.15K070643PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35K032431PRISMA M60/M100 SETSK896758GAMBRO BICARBONATE MONITOR BCM 10-3K896757GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWSK902481GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER

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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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