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FDA 510(k)

CAVH/CVVH/CAVHD SET MODEL #HT-HF/505

K-Number: K921597 · 1995-02-24

ApplicantHaemotronic, Inc.
Decision Date1995-02-24
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CAVH/CVVH/CAVHD SET MODEL #HT-HF/505 is the device name listed in this FDA 510(k) record. The listed applicant is Haemotronic, Inc.. It received FDA 510(k) clearance on 1995-02-24 under 510(k) number K921597. 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 CAVH/CVVH/CAVHD SET MODEL #HT-HF/505?

CAVH/CVVH/CAVHD SET MODEL #HT-HF/505 is a medical device that received FDA 510(k) clearance on 1995-02-24. The listed applicant is Haemotronic, Inc.. The 510(k) number is K921597.

When did CAVH/CVVH/CAVHD SET MODEL #HT-HF/505 receive FDA 510(k) clearance?

CAVH/CVVH/CAVHD SET MODEL #HT-HF/505 received FDA 510(k) clearance on 1995-02-24, under 510(k) number K921597.

Who is the listed applicant for CAVH/CVVH/CAVHD SET MODEL #HT-HF/505?

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

What is the FDA product code for CAVH/CVVH/CAVHD SET MODEL #HT-HF/505?

The FDA product code for CAVH/CVVH/CAVHD SET MODEL #HT-HF/505 is FJK.

Related Clinical Trials

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Other records listing Haemotronic, 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.

K921594HAEMOTROL MODEL #HT-SB/6 BURETTE SETK921595Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2K913361DRAIN/PRIMING/RECIRCULATION BAG

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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