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)

COLAB COCATH(TM) IMPLANTED CATHETER AND DEPOT

K-Number: K896197 · 1990-07-11

ApplicantColab Intl., Inc.
Decision Date1990-07-11
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COLAB COCATH(TM) IMPLANTED CATHETER AND DEPOT is the device name listed in this FDA 510(k) record. The listed applicant is Colab Intl., Inc.. It received FDA 510(k) clearance on 1990-07-11 under 510(k) number K896197. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLAB COCATH(TM) IMPLANTED CATHETER AND DEPOT?

COLAB COCATH(TM) IMPLANTED CATHETER AND DEPOT is a medical device that received FDA 510(k) clearance on 1990-07-11. The listed applicant is Colab Intl., Inc.. The 510(k) number is K896197.

When did COLAB COCATH(TM) IMPLANTED CATHETER AND DEPOT receive FDA 510(k) clearance?

COLAB COCATH(TM) IMPLANTED CATHETER AND DEPOT received FDA 510(k) clearance on 1990-07-11, under 510(k) number K896197.

Who is the listed applicant for COLAB COCATH(TM) IMPLANTED CATHETER AND DEPOT?

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

What is the FDA product code for COLAB COCATH(TM) IMPLANTED CATHETER AND DEPOT?

The FDA product code for COLAB COCATH(TM) IMPLANTED CATHETER AND DEPOT is KXK.

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

Related Devices (Code: KXK)

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.

K252296OncoPatchOncopatch, Inc.K242818IsoSphereIsoaid, LLCK223465RadianceTx Radionuclide Brachytherapy SourceRadiance Therapeutics, Inc.K221539GammaTileGt Medical TechnologiesK202267Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesIsoray Medical, Inc.K193602LV Liberty Vision Model 1 90Yttrium Brachytherapy SourceLv Liberty Vision Corporation

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.

↑