Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ASA BLOOD TUBING LINES

K-Number: K854271 · 1985-11-05

ApplicantOrganon Teknika Corp.
Decision Date1985-11-05
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ASA BLOOD TUBING LINES is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1985-11-05 under 510(k) number K854271. 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 ASA BLOOD TUBING LINES?

ASA BLOOD TUBING LINES is a medical device that received FDA 510(k) clearance on 1985-11-05. The listed applicant is Organon Teknika Corp.. The 510(k) number is K854271.

When did ASA BLOOD TUBING LINES receive FDA 510(k) clearance?

ASA BLOOD TUBING LINES received FDA 510(k) clearance on 1985-11-05, under 510(k) number K854271.

Who is the listed applicant for ASA BLOOD TUBING LINES?

The FDA 510(k) record lists Organon Teknika Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASA BLOOD TUBING LINES?

The FDA product code for ASA BLOOD TUBING LINES is FJK.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Organon Teknika Corp. 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.

K003104BACT/ALERT CSRK000492MDA D-DIMERK000378BACT/ALERT MB CULTURE BOTTLEK994343BACT/ALERT SVK993423BACT/ALERT SAK993421BACT/ALERT SN

View all 130 devices →

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.

↑