Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

COBE CENTRY 2 VARIABLE CONCENTRATE-18-

K-Number: K802895 · 1980-12-22

ApplicantCobe Laboratories, Inc.
Decision Date1980-12-22
Product CodeKDC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COBE CENTRY 2 VARIABLE CONCENTRATE-18- is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Laboratories, Inc.. It received FDA 510(k) clearance on 1980-12-22 under 510(k) number K802895. The device is classified under product code KDC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBE CENTRY 2 VARIABLE CONCENTRATE-18-?

COBE CENTRY 2 VARIABLE CONCENTRATE-18- is a medical device that received FDA 510(k) clearance on 1980-12-22. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K802895.

When did COBE CENTRY 2 VARIABLE CONCENTRATE-18- receive FDA 510(k) clearance?

COBE CENTRY 2 VARIABLE CONCENTRATE-18- received FDA 510(k) clearance on 1980-12-22, under 510(k) number K802895.

Who is the listed applicant for COBE CENTRY 2 VARIABLE CONCENTRATE-18-?

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

What is the FDA product code for COBE CENTRY 2 VARIABLE CONCENTRATE-18-?

The FDA product code for COBE CENTRY 2 VARIABLE CONCENTRATE-18- is KDC.

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 Cobe Laboratories, 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.

K923272COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATORK900105COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTICK905793COBE CENTRY 2 BICART OPTION KITK905388COBE CENTRYSYSTEM 3 BICART OPTION KITK904336NEW COBE SATURATION/HEMATOCRIT MONITORK902631COBE ICU CONVERSION KIT

View all 77 devices →

Related Devices (Code: KDC)

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.

K943229DISPOSABLE SURGICAL SCISSORS AND FORCEPSY.M.K. International Co., Ltd.K936226SURGIMED BREAST LOCALIZATION NEEDLE WIRE SETMeadox Medicals, Div. Boston Scientific Corp.K920153THERMUFF BAGTechstylesK920263MANUAL SURGICAL INSTRUMENTSPhoenix Instruments Div.K915064DISPOSABLE CAUTERY ABRASIVE PADAmerican Medical Mfg., Inc.K914960INSTRUMENT ORGANIZERO.R. Concepts, 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.

↑