FDA 510(k)

ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN

K-Number: K083763 · 2009-03-16

Decision Date2009-03-16

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN is the device name listed in this FDA 510(k) record. The listed applicant is R4 Vascular, Inc.. It received FDA 510(k) clearance on 2009-03-16 under 510(k) number K083763. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN?

ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN is a medical device that received FDA 510(k) clearance on 2009-03-16. The listed applicant is R4 Vascular, Inc.. The 510(k) number is K083763.

When did ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN receive FDA 510(k) clearance?

ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN received FDA 510(k) clearance on 2009-03-16, under 510(k) number K083763.

Who is the listed applicant for ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN?

The FDA 510(k) record lists R4 Vascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN?

The FDA product code for ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN is LJS.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing R4 Vascular, Inc. as applicant

K131329VECTOR PTA BALLOON DILATATION CATHETER K121385VECTOR K100169DURASPAN HEMODIALYSIS LONG-TERM CATHETER K091506DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520 K092040PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 430103240 K071361R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,005

View all 7 devices →

Related Devices (Code: LJS)

K260929Neonav ECG Tip Location SystemNavi Medical Technologies K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve TechnologySpectrum Vascular K252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc.K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); HydrAccess Vascular, Inc.K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)Access Vascular, Inc.K243484PM2+ System and SmartPICC StyletPiccolo 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.