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FDA 510(k)

PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM)

K-Number: K874650 · 1987-12-09

ApplicantQuinton, Inc.
Decision Date1987-12-09
Product CodeFKO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM) is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1987-12-09 under 510(k) number K874650. 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 PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM)?

PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM) is a medical device that received FDA 510(k) clearance on 1987-12-09. The listed applicant is Quinton, Inc.. The 510(k) number is K874650.

When did PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM) receive FDA 510(k) clearance?

PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM) received FDA 510(k) clearance on 1987-12-09, under 510(k) number K874650.

Who is the listed applicant for PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM)?

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 DIALYSIS KIT (ACUTE AND CHRONIC FORM)?

The FDA product code for PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM) is FKO.

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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: 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.K872221DIALY-NATE SET & DIALY-NATE CATHETERGesco Intl., Inc.K871730MODIFIED USE OF PULL-APART INTRODUCER SETQuinton, 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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