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

FDA 510(k)

Firefly Peritoneal Dialysis Connector Disinfection System

K-Number: K151620 · 2016-01-20

ApplicantPuracath Medical, Inc.
Decision Date2016-01-20
Product CodeKDJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Firefly Peritoneal Dialysis Connector Disinfection System is a medical device manufactured by Puracath Medical, Inc.. It received FDA 510(k) clearance on 2016-01-20 under approval number K151620. The device is classified under product code KDJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Firefly Peritoneal Dialysis Connector Disinfection System?

Firefly Peritoneal Dialysis Connector Disinfection System is a medical device that received FDA 510(k) clearance on 2016-01-20. It is manufactured by Puracath Medical, Inc.. The 510(k) number is K151620.

When was Firefly Peritoneal Dialysis Connector Disinfection System approved by the FDA?

Firefly Peritoneal Dialysis Connector Disinfection System received FDA 510(k) clearance on 2016-01-20, under approval number K151620.

What company makes Firefly Peritoneal Dialysis Connector Disinfection System?

Firefly Peritoneal Dialysis Connector Disinfection System is manufactured by Puracath Medical, Inc..

What is the FDA product code for Firefly Peritoneal Dialysis Connector Disinfection System?

The FDA product code for Firefly Peritoneal Dialysis Connector Disinfection System is KDJ.

Related Clinical Trials

NCT07612124 Evaluation of the Application of Intelligent Applications in Patients Undergoing Peritoneal Dialysis COMPLETED NCT07522944 AI-Guided Relaxation for Hemodialysis Anxiety RECRUITING NCT05143164 Hydrocolloid Dressing for Catheter Exit Site Care in Peritoneal Dialysis Patients COMPLETED NCT06832696 Assessment of a Wearable Ultrafiltration Device NOT_YET_RECRUITING NCT07253662 Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Patients With Peritoneal Metastasis From Pancreatic Adenocarcinoma RECRUITING NCT07216885 Solv Multi-Pass Hemodialysis System In-Center Clinical Study RECRUITING

Other Devices by Puracath Medical, Inc.

K203796Firefly Needleless Connector K251375PuraCath Firefly Needleless Connector IT (9005)

Related Devices (Code: KDJ)

K173593stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inchFresenius Medical Care Renal Therapies Group, LLC K173651Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain SetFresenius Medical Care Renal Therapies Group, LLC K173363Cycler Drain Bag SetFresenius Medical Care Renal Therapies Group, LLC K192705MiniCap Extended Life PD Transfer SetsBaxter Healthcare K21401615L Cycler Drainage BagBaxter Healthcare Corporation K231849MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483Baxter Healthcare

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.

↑