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FDA 510(k)

EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE

K-Number: K063293 · 2007-03-23

ApplicantEdwards Lifesciences Services GmbH
Decision Date2007-03-23
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences Services GmbH. It received FDA 510(k) clearance on 2007-03-23 under 510(k) number K063293. 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 EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE?

EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE is a medical device that received FDA 510(k) clearance on 2007-03-23. The listed applicant is Edwards Lifesciences Services GmbH. The 510(k) number is K063293.

When did EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE receive FDA 510(k) clearance?

EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE received FDA 510(k) clearance on 2007-03-23, under 510(k) number K063293.

Who is the listed applicant for EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE?

The FDA 510(k) record lists Edwards Lifesciences Services GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE?

The FDA product code for EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE is FJK.

Related Clinical Trials

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Other records listing Edwards Lifesciences Services GmbH 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.

K090682EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00K070320EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01

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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