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)

ATRIUM THORACIC CATHETER

K-Number: K831931 · 1983-10-04

ApplicantAtrium Medical Corp.
Decision Date1983-10-04
Product CodeGBZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ATRIUM THORACIC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Atrium Medical Corp.. It received FDA 510(k) clearance on 1983-10-04 under 510(k) number K831931. The device is classified under product code GBZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATRIUM THORACIC CATHETER?

ATRIUM THORACIC CATHETER is a medical device that received FDA 510(k) clearance on 1983-10-04. The listed applicant is Atrium Medical Corp.. The 510(k) number is K831931.

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

ATRIUM THORACIC CATHETER received FDA 510(k) clearance on 1983-10-04, under 510(k) number K831931.

Who is the listed applicant for ATRIUM THORACIC CATHETER?

The FDA 510(k) record lists Atrium Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATRIUM THORACIC CATHETER?

The FDA product code for ATRIUM THORACIC CATHETER is GBZ.

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 Atrium Medical Corp. 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.

K130131EDRAIN CHEST DRAINAGE SYSTEMK122138ATRIUM FLIXENE IFG VASCULAR GRAFTK121070C-QUR RPM MESHK113112CLEARWAY RX NB CATHETERK102596ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFTK093431CLEARWAY OTW MODEL 85912

View all 63 devices →

Related Devices (Code: GBZ)

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.

K973621PRE-VIEW CHOLANGIOGRAPHY CLAMPNashville Surgical InstrumentsK944790FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERApplied Medical ResourcesK942450ENDOPATHEthicon Endo-Surgery, Inc.K932228MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETERBoston Scientific CorpK926217TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USETerumo Medical Corp.K926143ANGIOLAPCATH CHOLANGIOGRAPHY KITBd Becton Dickinson Vacutainer Systems Preanalytic

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.

↑