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)

NIAGARA DUAL LUMEN CATHETER

K-Number: K965178 · 1997-08-19

ApplicantVas-Cath, Inc.
Decision Date1997-08-19
Product CodeMPB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NIAGARA DUAL LUMEN CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Vas-Cath, Inc.. It received FDA 510(k) clearance on 1997-08-19 under 510(k) number K965178. The device is classified under product code MPB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIAGARA DUAL LUMEN CATHETER?

NIAGARA DUAL LUMEN CATHETER is a medical device that received FDA 510(k) clearance on 1997-08-19. The listed applicant is Vas-Cath, Inc.. The 510(k) number is K965178.

When did NIAGARA DUAL LUMEN CATHETER receive FDA 510(k) clearance?

NIAGARA DUAL LUMEN CATHETER received FDA 510(k) clearance on 1997-08-19, under 510(k) number K965178.

Who is the listed applicant for NIAGARA DUAL LUMEN CATHETER?

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

What is the FDA product code for NIAGARA DUAL LUMEN CATHETER?

The FDA product code for NIAGARA DUAL LUMEN CATHETER is MPB.

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 Vas-Cath, 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.

K973013OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETERK964881ULTRAVERSE PTA CATHETERK970725OPTI-PLAST XL 5.5 F PTA CATHETERK941706OPTI-PLAST ANGIOPLASTY CATHETERK925485VAS-CATH INC. OPTI-PLAST ANGIOPLASTY CATHETERK933483OPTI-PLAST 5F PTA CATHETERS

View all 27 devices →

Related Devices (Code: MPB)

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.

K25083614F Duo-Flow® Side X Side Double Lumen CatheterMedical Components, Inc.K200426Acute Dual Lumen Hemodialysis CatheterHealth Line International CorporationK192807Duo-Flow Side x Side Double Lumen CatheterMedical Components, Inc. (dba MedComp)K192302Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen CatheterCovidien, LLCK163458Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc.K161504Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/TrayCook Incorporated

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.

↑