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FDA 510(k)

LONG TERM PERITONEAL CATHETER

K-Number: K854614 · 1985-12-19

ApplicantThermadics, Inc.
Decision Date1985-12-19
Product CodeFJS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LONG TERM PERITONEAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Thermadics, Inc.. It received FDA 510(k) clearance on 1985-12-19 under 510(k) number K854614. 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 LONG TERM PERITONEAL CATHETER?

LONG TERM PERITONEAL CATHETER is a medical device that received FDA 510(k) clearance on 1985-12-19. The listed applicant is Thermadics, Inc.. The 510(k) number is K854614.

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

LONG TERM PERITONEAL CATHETER received FDA 510(k) clearance on 1985-12-19, under 510(k) number K854614.

Who is the listed applicant for LONG TERM PERITONEAL CATHETER?

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

What is the FDA product code for LONG TERM PERITONEAL CATHETER?

The FDA product code for LONG TERM PERITONEAL 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.

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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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