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)

CHEST CATHETERS/THORACIC CATHETERS

K-Number: K851048 · 1985-06-05

ApplicantMedovations, Inc.
Decision Date1985-06-05
Product CodeGBS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CHEST CATHETERS/THORACIC CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Medovations, Inc.. It received FDA 510(k) clearance on 1985-06-05 under 510(k) number K851048. 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 CHEST CATHETERS/THORACIC CATHETERS?

CHEST CATHETERS/THORACIC CATHETERS is a medical device that received FDA 510(k) clearance on 1985-06-05. The listed applicant is Medovations, Inc.. The 510(k) number is K851048.

When did CHEST CATHETERS/THORACIC CATHETERS receive FDA 510(k) clearance?

CHEST CATHETERS/THORACIC CATHETERS received FDA 510(k) clearance on 1985-06-05, under 510(k) number K851048.

Who is the listed applicant for CHEST CATHETERS/THORACIC CATHETERS?

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

What is the FDA product code for CHEST CATHETERS/THORACIC CATHETERS?

The FDA product code for CHEST CATHETERS/THORACIC CATHETERS 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 Medovations, 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.

K002363MEDOVATIONS ESOPHAGEAL DILATORK972119MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)K924646OVER THE GUIDEWIRE DILATATION SYSTEMK913678TROCAR CATHETERK905478YANKAUER SUCTION DEVICEK874309URETHAL CATHETER

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.

↑