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)

CCPD CYCLER SET W/5 PRONGED CONNECTOR

K-Number: K822545 · 1982-10-13

ApplicantAmerican Medical Products, Inc.
Decision Date1982-10-13
Product CodeFKX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CCPD CYCLER SET W/5 PRONGED CONNECTOR is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Products, Inc.. It received FDA 510(k) clearance on 1982-10-13 under 510(k) number K822545. The device is classified under product code FKX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CCPD CYCLER SET W/5 PRONGED CONNECTOR?

CCPD CYCLER SET W/5 PRONGED CONNECTOR is a medical device that received FDA 510(k) clearance on 1982-10-13. The listed applicant is American Medical Products, Inc.. The 510(k) number is K822545.

When did CCPD CYCLER SET W/5 PRONGED CONNECTOR receive FDA 510(k) clearance?

CCPD CYCLER SET W/5 PRONGED CONNECTOR received FDA 510(k) clearance on 1982-10-13, under 510(k) number K822545.

Who is the listed applicant for CCPD CYCLER SET W/5 PRONGED CONNECTOR?

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

What is the FDA product code for CCPD CYCLER SET W/5 PRONGED CONNECTOR?

The FDA product code for CCPD CYCLER SET W/5 PRONGED CONNECTOR is FKX.

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 American Medical Products, 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.

K922290SINGLE-STEP PREGNANCY, HCG TESTK862221E-Z CLEANK861251AMP CLOSED URINARY DRAINAGE BAG, 1011 & 1011NK830881AMPERCIDE DISINFECTANT ACCESSORY TO -K823827AMP 80/2 OUTFLOW MONITOR MODIFICATIONK822548SAFE LOCK CATHETER S-3

View all 30 devices →

Related Devices (Code: FKX)

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.

K250523Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5)Simergent, LLCK243371Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1Byonyks Pvt, Ltd.K220935Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone AppIren-Medical, Ltd.K222318Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLCK212522Lilliput APD SystemFresenius Medical Care Renal Therapies Group, LLCK212658CloudCath Peritoneal Dialysis Drain Set Monitoring SystemCloudcath

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.

↑