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)

INTIMAX(TM) IRRIGATION CATHETER

K-Number: K911181 · 1991-04-18

ApplicantApplied Vascular Devices, Inc.
Decision Date1991-04-18
Product CodeGCA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INTIMAX(TM) IRRIGATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Applied Vascular Devices, Inc.. It received FDA 510(k) clearance on 1991-04-18 under 510(k) number K911181. The device is classified under product code GCA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTIMAX(TM) IRRIGATION CATHETER?

INTIMAX(TM) IRRIGATION CATHETER is a medical device that received FDA 510(k) clearance on 1991-04-18. The listed applicant is Applied Vascular Devices, Inc.. The 510(k) number is K911181.

When did INTIMAX(TM) IRRIGATION CATHETER receive FDA 510(k) clearance?

INTIMAX(TM) IRRIGATION CATHETER received FDA 510(k) clearance on 1991-04-18, under 510(k) number K911181.

Who is the listed applicant for INTIMAX(TM) IRRIGATION CATHETER?

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

What is the FDA product code for INTIMAX(TM) IRRIGATION CATHETER?

The FDA product code for INTIMAX(TM) IRRIGATION CATHETER is GCA.

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 Applied Vascular Devices, 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.

K911730SURGICAL OBTURATOR WITH SEALK911589DISPOSABLE SURGICAL TROCAR WITH SEALK910339AVD INTIMAX OCCLUSION CATHETERK910372INTIMAX THROMBECTOMY CATHETERK910493AVD INTIMAX CHOLANGIOGRAPHY CATHETERK903848DIAGNOSTIC INTRASCULAR CATHETER

View all 21 devices →

Related Devices (Code: GCA)

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.

K253013Disposable Stone Retrieval Balloon CatheterZhejiang Soudon Medical Technology Co., Ltd.K232752Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)Jiangsu Vedkang Medical Science and Technology Co., Ltd.K212582SpyGlass Discover Balloon Dilation CatheterBoston Scientific CorporationK210660Stone Retrieval Balloon CatheterAnrei Medical (Hangzhou) Co., Ltd.K200173Stone Retrieval BalloonHangzhou AGS MedTech Co., Ltd.K200247Fusion Quattro Extraction BalloonWilson-Cook Medical, 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.

↑