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)

LEMAITRE BILIARY CATHETER

K-Number: K992941 · 2000-01-12

ApplicantVascutech, Inc.
Decision Date2000-01-12
Product CodeLQR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LEMAITRE BILIARY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Vascutech, Inc.. It received FDA 510(k) clearance on 2000-01-12 under 510(k) number K992941. The device is classified under product code LQR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEMAITRE BILIARY CATHETER?

LEMAITRE BILIARY CATHETER is a medical device that received FDA 510(k) clearance on 2000-01-12. The listed applicant is Vascutech, Inc.. The 510(k) number is K992941.

When did LEMAITRE BILIARY CATHETER receive FDA 510(k) clearance?

LEMAITRE BILIARY CATHETER received FDA 510(k) clearance on 2000-01-12, under 510(k) number K992941.

Who is the listed applicant for LEMAITRE BILIARY CATHETER?

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

What is the FDA product code for LEMAITRE BILIARY CATHETER?

The FDA product code for LEMAITRE BILIARY CATHETER is LQR.

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 Vascutech, 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.

K001621DARDIK CAROTID SHUNTK992942LEMAITRE OCCLUSION CATHETERK992933LEMAITRE IRRIGATION CATHETERK992934LEMAITRE VENOUS THROMBECTOMY CATHETERK992940LEMAITRE BALLOON CATHETER WITH IRRIGATIONK992368LEMAITRE EMBOLECTOMY CATHETER

View all 14 devices →

Related Devices (Code: LQR)

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.

K253056Disposable Stone Extraction BasketZhejiang Soudon Medical Technology Co., Ltd.K243807Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432POlympus Medical Systems Corp.K243471Extraction BasketMicro-Tech (Nanjing) Co., Ltd.K240192Single-use Extraction BasketsScivita Medical Technology Co., Ltd.K230598Stone Extraction BasketsJiangsu Vedkang Medical Science and Technology Co., Ltd.K203322SpyGlass Discover Retrieval BasketBoston Scientific 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.

↑