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FDA 510(k)

GAMBRO CARTRIDGE BLOOD SETS

K-Number: K070414 · 2007-10-12

ApplicantGambro Renal Products
Decision Date2007-10-12
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GAMBRO CARTRIDGE BLOOD SETS is the device name listed in this FDA 510(k) record. The listed applicant is Gambro Renal Products. It received FDA 510(k) clearance on 2007-10-12 under 510(k) number K070414. 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 GAMBRO CARTRIDGE BLOOD SETS?

GAMBRO CARTRIDGE BLOOD SETS is a medical device that received FDA 510(k) clearance on 2007-10-12. The listed applicant is Gambro Renal Products. The 510(k) number is K070414.

When did GAMBRO CARTRIDGE BLOOD SETS receive FDA 510(k) clearance?

GAMBRO CARTRIDGE BLOOD SETS received FDA 510(k) clearance on 2007-10-12, under 510(k) number K070414.

Who is the listed applicant for GAMBRO CARTRIDGE BLOOD SETS?

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

What is the FDA product code for GAMBRO CARTRIDGE BLOOD SETS?

The FDA product code for GAMBRO CARTRIDGE BLOOD SETS is FJK.

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Other records listing Gambro Renal Products 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.

K120333PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPYK072908PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPYK063290GAMBRO QUICKSET BLOODLINESK062090PRISMA SYSTEM R03.10AK060195GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USEK051520GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H

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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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