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FDA 510(k)

ACUTE PERITONEAL DIALYSIS CATHETERS

K-Number: K854966 · 1986-01-09

ApplicantThermedics, Inc.
Decision Date1986-01-09
Product CodeFKO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ACUTE 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 1986-01-09 under 510(k) number K854966. The device is classified under product code FKO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUTE PERITONEAL DIALYSIS CATHETERS?

ACUTE PERITONEAL DIALYSIS CATHETERS is a medical device that received FDA 510(k) clearance on 1986-01-09. The listed applicant is Thermedics, Inc.. The 510(k) number is K854966.

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

ACUTE PERITONEAL DIALYSIS CATHETERS received FDA 510(k) clearance on 1986-01-09, under 510(k) number K854966.

Who is the listed applicant for ACUTE 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 ACUTE PERITONEAL DIALYSIS CATHETERS?

The FDA product code for ACUTE PERITONEAL DIALYSIS CATHETERS is FKO.

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. 50-1000K863128PERITONEAL DIALYSIS CATHETERSK850076WOUND DRESSING MODEL ZB-6

Related Devices (Code: FKO)

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.

K964514CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSISCorpak, Inc.K974570PERITONEAL DIALYSIS CATHETER CONNECTORMedigroup, Inc.K910787TITANIUM CONNECTOR (2 PART)Accurate Surgical Instruments Co.K885037AMUKIN 50% - AIRSPRAY(R)Bernard J. Cooney, P.A.K874650PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM)Quinton, Inc.K872221DIALY-NATE SET & DIALY-NATE CATHETERGesco Intl., Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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