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)

SURECATH - ITP II PERCUTANEOUS PORT ACCESS DEVICE

K-Number: K875213 · 1988-03-03

ApplicantTitan Medical, Inc.
Decision Date1988-03-03
Product CodeLJT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURECATH - ITP II PERCUTANEOUS PORT ACCESS DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Titan Medical, Inc.. It received FDA 510(k) clearance on 1988-03-03 under 510(k) number K875213. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURECATH - ITP II PERCUTANEOUS PORT ACCESS DEVICE?

SURECATH - ITP II PERCUTANEOUS PORT ACCESS DEVICE is a medical device that received FDA 510(k) clearance on 1988-03-03. The listed applicant is Titan Medical, Inc.. The 510(k) number is K875213.

When did SURECATH - ITP II PERCUTANEOUS PORT ACCESS DEVICE receive FDA 510(k) clearance?

SURECATH - ITP II PERCUTANEOUS PORT ACCESS DEVICE received FDA 510(k) clearance on 1988-03-03, under 510(k) number K875213.

Who is the listed applicant for SURECATH - ITP II PERCUTANEOUS PORT ACCESS DEVICE?

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

What is the FDA product code for SURECATH - ITP II PERCUTANEOUS PORT ACCESS DEVICE?

The FDA product code for SURECATH - ITP II PERCUTANEOUS PORT ACCESS DEVICE is LJT.

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 Titan Medical, 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.

K872149SURECATH-ITP PERCUTANEOUS ACCESS KITK870542VASCATH VASCULAR CATHETER PLACEMENT KIT

Related Devices (Code: LJT)

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.

K260916FLEXI-PORT™ Power Injectable Implantable PortPortal Access, Inc.K252478Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable PortBard Access Systems, Inc.K251253PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable PortBard Access Systems, Inc.K242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable PortsBard Access Systems, Inc.K232737PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable Port; PowerPort™ isp M.R.I.™ ECG Enabled Implantable Port; PowerPort™ Slim ECG Enabled Implantable PortBard Peripheral Vascular, Inc.K190559SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsAngioDynamics, 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.

↑