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FDA 510(k)

PERITONEAL DIALYSIS CATHETERS

K-Number: K863128 · 1986-09-09

ApplicantThermedics, Inc.
Decision Date1986-09-09
Product CodeFJS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PERITONEAL DIALYSIS CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Thermedics, Inc.. It received FDA 510(k) clearance on 1986-09-09 under 510(k) number K863128. 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 CATHETERS?

PERITONEAL DIALYSIS CATHETERS is a medical device that received FDA 510(k) clearance on 1986-09-09. The listed applicant is Thermedics, Inc.. The 510(k) number is K863128.

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

PERITONEAL DIALYSIS CATHETERS received FDA 510(k) clearance on 1986-09-09, under 510(k) number K863128.

Who is the listed applicant for PERITONEAL DIALYSIS CATHETERS?

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

What is the FDA product code for PERITONEAL DIALYSIS CATHETERS?

The FDA product code for PERITONEAL DIALYSIS CATHETERS 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

Other records listing Thermedics, 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.

K894131DERMAPORT VASCULAR ACCESS DEVICE MODEL NO. 50-1000K854966ACUTE PERITONEAL DIALYSIS CATHETERSK850076WOUND DRESSING MODEL ZB-6

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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