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FDA 510(k)

PERITONEAL DIALYSIS CATHETER

K-Number: K771555 · 1977-11-28

ApplicantFluoro-Mold Co.
Decision Date1977-11-28
Product CodeFJS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PERITONEAL DIALYSIS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Fluoro-Mold Co.. It received FDA 510(k) clearance on 1977-11-28 under 510(k) number K771555. The device is classified under product code FJS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERITONEAL DIALYSIS CATHETER?

PERITONEAL DIALYSIS CATHETER is a medical device that received FDA 510(k) clearance on 1977-11-28. The listed applicant is Fluoro-Mold Co.. The 510(k) number is K771555.

When did PERITONEAL DIALYSIS CATHETER receive FDA 510(k) clearance?

PERITONEAL DIALYSIS CATHETER received FDA 510(k) clearance on 1977-11-28, under 510(k) number K771555.

Who is the listed applicant for PERITONEAL DIALYSIS CATHETER?

The FDA 510(k) record lists Fluoro-Mold Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERITONEAL DIALYSIS CATHETER?

The FDA product code for PERITONEAL DIALYSIS CATHETER is FJS.

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

Related Devices (Code: FJS)

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.

K213602Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool KitCovidien, LLCK180485Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter ExtenderCovidien, LLCK130441FALLER STYLETMedionics International, Inc.K121383PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)Medical Components, Inc.K120130FALLER TROCARMedigroup, Inc.K113354VETA PERITONEAL DIALYSIS CATHETERPfm 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.

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