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FDA 510(k)

SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS

K-Number: K864784 · 1987-01-20

ApplicantCd Medical, Inc.
Decision Date1987-01-20
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Cd Medical, Inc.. It received FDA 510(k) clearance on 1987-01-20 under 510(k) number K864784. 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 SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS?

SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS is a medical device that received FDA 510(k) clearance on 1987-01-20. The listed applicant is Cd Medical, Inc.. The 510(k) number is K864784.

When did SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS receive FDA 510(k) clearance?

SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS received FDA 510(k) clearance on 1987-01-20, under 510(k) number K864784.

Who is the listed applicant for SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS?

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

What is the FDA product code for SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS?

The FDA product code for SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS is FJK.

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Other records listing Cd Medical, 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.

K925654CD HOME DIALYSERVICE HEMODIALYSIS TRAYK910215DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTK901520WURTZ CHOLEY CLIP (TM)K894106DRAKE WILLOCK REVERSE OSMOSIS WATER TREATMENT SYSTK884353ULTRX(TM) 850 ARTIFICIAL KIDNEYK880459480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE

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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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