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FDA 510(k)

CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS

K-Number: K964514 · 1998-06-26

ApplicantCorpak, Inc.
Decision Date1998-06-26
Product CodeFKO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Corpak, Inc.. It received FDA 510(k) clearance on 1998-06-26 under 510(k) number K964514. 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 CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS?

CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS is a medical device that received FDA 510(k) clearance on 1998-06-26. The listed applicant is Corpak, Inc.. The 510(k) number is K964514.

When did CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS receive FDA 510(k) clearance?

CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS received FDA 510(k) clearance on 1998-06-26, under 510(k) number K964514.

Who is the listed applicant for CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS?

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

What is the FDA product code for CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS?

The FDA product code for CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS 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 Corpak, 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.

K970178CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEMK944750CORFLO 300 PUMP

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.

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.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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