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)

ACI SILICATH THORACIC CATHETER

K-Number: K942335 · 1994-08-09

ApplicantAmerican Catheter
Decision Date1994-08-09
Product CodeGBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACI SILICATH THORACIC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is American Catheter. It received FDA 510(k) clearance on 1994-08-09 under 510(k) number K942335. The device is classified under product code GBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACI SILICATH THORACIC CATHETER?

ACI SILICATH THORACIC CATHETER is a medical device that received FDA 510(k) clearance on 1994-08-09. The listed applicant is American Catheter. The 510(k) number is K942335.

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

ACI SILICATH THORACIC CATHETER received FDA 510(k) clearance on 1994-08-09, under 510(k) number K942335.

Who is the listed applicant for ACI SILICATH THORACIC CATHETER?

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

What is the FDA product code for ACI SILICATH THORACIC CATHETER?

The FDA product code for ACI SILICATH THORACIC CATHETER is GBX.

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: GBX)

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.

K082725GRAFTGUARD PRESSURE CONTROLLING SYRINGEMaquet Cardiovascular, LLCK052286DEUTSCH ANTI-BLOCKAGE WOUND DRAINThe Catheter Exchange, Inc.K043515GRAFTSAVERVescare, Inc.K013417MISONIX IRRIGATION SYSTEM MOEDL BC20PMisonix, Inc.K000704DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)Dmc Medical, Ltd.K974233LYSONIX IRRIGATION SYSTEMLysonix, 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.

↑