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)

WALRUS: DOUBLE BALLOON SHUNTING CATHETER

K-Number: K862190 · 1986-11-03

ApplicantMedical Parameters, Inc.
Decision Date1986-11-03
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WALRUS: DOUBLE BALLOON SHUNTING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Medical Parameters, Inc.. It received FDA 510(k) clearance on 1986-11-03 under 510(k) number K862190. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WALRUS: DOUBLE BALLOON SHUNTING CATHETER?

WALRUS: DOUBLE BALLOON SHUNTING CATHETER is a medical device that received FDA 510(k) clearance on 1986-11-03. The listed applicant is Medical Parameters, Inc.. The 510(k) number is K862190.

When did WALRUS: DOUBLE BALLOON SHUNTING CATHETER receive FDA 510(k) clearance?

WALRUS: DOUBLE BALLOON SHUNTING CATHETER received FDA 510(k) clearance on 1986-11-03, under 510(k) number K862190.

Who is the listed applicant for WALRUS: DOUBLE BALLOON SHUNTING CATHETER?

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

What is the FDA product code for WALRUS: DOUBLE BALLOON SHUNTING CATHETER?

The FDA product code for WALRUS: DOUBLE BALLOON SHUNTING CATHETER is DWF.

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 Medical Parameters, 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.

K844444ESOPHAGEAL STETHOSCOPEK833825MULTI-LUMEN INTRAVENOUS INFUSION CATHK830754BLOOD PRESSURE MONITORING KITS,WALRUSK831239WALRUS PERCUTANEOUS INTRODUCER SETK830755I.V. SETS WALRUS BRAND VARIOUS CONFIGUR-

Related Devices (Code: DWF)

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.

K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.K250937Venous Return CannulaeLivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart ReactorsK253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L.K253998Clearview Intracoronary ShuntsMedtronic, 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.

↑