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)

PLASMA THERAPY TUBESET-E100 SERIES

K-Number: K831747 · 1983-06-30

ApplicantParker Hannifin Corp.
Decision Date1983-06-30
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PLASMA THERAPY TUBESET-E100 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Parker Hannifin Corp.. It received FDA 510(k) clearance on 1983-06-30 under 510(k) number K831747. 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 PLASMA THERAPY TUBESET-E100 SERIES?

PLASMA THERAPY TUBESET-E100 SERIES is a medical device that received FDA 510(k) clearance on 1983-06-30. The listed applicant is Parker Hannifin Corp.. The 510(k) number is K831747.

When did PLASMA THERAPY TUBESET-E100 SERIES receive FDA 510(k) clearance?

PLASMA THERAPY TUBESET-E100 SERIES received FDA 510(k) clearance on 1983-06-30, under 510(k) number K831747.

Who is the listed applicant for PLASMA THERAPY TUBESET-E100 SERIES?

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

What is the FDA product code for PLASMA THERAPY TUBESET-E100 SERIES?

The FDA product code for PLASMA THERAPY TUBESET-E100 SERIES 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 Parker Hannifin 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.

K161731Cleveland Multiport Ventricular Catheter SetK897086PARKER AMBULATORY MEDICATION INFUSION PUMP 2004K863532MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSERK834461INFUSION PUMP PRIMERK833723MODEL 2000 AMBULATORY MED. INFUSERK831402PRESSURE MONITOR & CONTROL UNIT APC-02A

View all 8 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.

↑