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)

DISPOSABLE THORACIC CATHETER

K-Number: K813587 · 1982-01-12

ApplicantTexas Medical Products, Inc.
Decision Date1982-01-12
Product CodeGBS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE THORACIC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Texas Medical Products, Inc.. It received FDA 510(k) clearance on 1982-01-12 under 510(k) number K813587. The device is classified under product code GBS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE THORACIC CATHETER?

DISPOSABLE THORACIC CATHETER is a medical device that received FDA 510(k) clearance on 1982-01-12. The listed applicant is Texas Medical Products, Inc.. The 510(k) number is K813587.

When did DISPOSABLE THORACIC CATHETER receive FDA 510(k) clearance?

DISPOSABLE THORACIC CATHETER received FDA 510(k) clearance on 1982-01-12, under 510(k) number K813587.

Who is the listed applicant for DISPOSABLE THORACIC CATHETER?

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

What is the FDA product code for DISPOSABLE THORACIC CATHETER?

The FDA product code for DISPOSABLE THORACIC CATHETER is GBS.

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 Texas Medical Products, 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.

K893417SURGIFRESH SUB-MICRON MASK NO. 901008-000K870932SURGIFRESH SURGICAL SMOKE REMOVALK851575DR. BRUNO LNAGE MINI PHOTOMETERK830634CARDIOTOMY FILTERK810532DISPOSABLE STOPCOCKK810515DISPOSABLE 2-STAGE CANNULA

View all 30 devices →

Related Devices (Code: GBS)

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.

K912645ATRIUMS PDR THORACIC CATHETERAtrium Medical Corp.K883887AXIOM ATRAUM WOUND DRAINSAxiom, Inc.K881873INTRODUCTION/DRAINAGE CATHETER & ACCESSSheridan Catheter Corp.K880895URESIL WOUND DRAIN TROCARUresil Corp.K880376NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAPGenesis Industries, Inc.K873377CLOSED CHEST DRAINAGE SET W/SUTURESGish Biomedical, 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.

↑