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FDA 510(k)

PERITONEAL CATHETER-CHANGES-

K-Number: K833749 · 1983-12-27

ApplicantQuinton, Inc.
Decision Date1983-12-27
Product CodeFKX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PERITONEAL CATHETER-CHANGES- is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1983-12-27 under 510(k) number K833749. 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 PERITONEAL CATHETER-CHANGES-?

PERITONEAL CATHETER-CHANGES- is a medical device that received FDA 510(k) clearance on 1983-12-27. The listed applicant is Quinton, Inc.. The 510(k) number is K833749.

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

PERITONEAL CATHETER-CHANGES- received FDA 510(k) clearance on 1983-12-27, under 510(k) number K833749.

Who is the listed applicant for PERITONEAL CATHETER-CHANGES-?

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

What is the FDA product code for PERITONEAL CATHETER-CHANGES-?

The FDA product code for PERITONEAL CATHETER-CHANGES- is FKX.

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Other records listing Quinton, 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.

K032038PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601K021906QUINTON Q-CATH, MODEL 000460K003576Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503K001492QUINTON Q-STRESS, MODEL 000483K992908Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)K990866QUINTON MEDTRACK CR PLUS TREADMILL

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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.

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