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)

CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY)

K-Number: K872485 · 1987-08-12

ApplicantIdeas For Medicine, Inc.
Decision Date1987-08-12
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY) is the device name listed in this FDA 510(k) record. The listed applicant is Ideas For Medicine, Inc.. It received FDA 510(k) clearance on 1987-08-12 under 510(k) number K872485. The device is classified under product code DXE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY)?

CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY) is a medical device that received FDA 510(k) clearance on 1987-08-12. The listed applicant is Ideas For Medicine, Inc.. The 510(k) number is K872485.

When did CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY) receive FDA 510(k) clearance?

CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY) received FDA 510(k) clearance on 1987-08-12, under 510(k) number K872485.

Who is the listed applicant for CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY)?

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

What is the FDA product code for CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY)?

The FDA product code for CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY) is DXE.

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 Ideas For Medicine, 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.

K961883VERSA-CATH ARTERIAL CATHETERK962751IDEAS' DUAL PORTK961716VASO-SAFE ARTERIAL EMBOLECTOMY CATHETEK960715PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8FK960422PRUITT SAFETY OCCLUSION CATHETERK954713DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION)

View all 15 devices →

Related Devices (Code: DXE)

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.

K240078Fogarty Thru-Lumen Embolectomy CatheterEdwards Lifesciences, LLCK241330Fogarty Fortis Arterial Embolectomy CatheterEdwards LifesciencesK233820Fogarty Arterial Embolectomy Catheter with Gate ValveEdwards LifesciencesK233819Fogarty Venous Thrombectomy CathetersEdwards Lifesciences, LLCK233619Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy CathetersEdwards LifesciencesK213771Merlin Aspiration SystemMivi Neurovascular, 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.

↑