FDA 510(k)

STRATO/INFUSAID TUNNELER

K-Number: K950987 · 1995-06-02

Decision Date1995-06-02

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

STRATO/INFUSAID TUNNELER is the device name listed in this FDA 510(k) record. The listed applicant is Strato/Infusaid, Inc.. It received FDA 510(k) clearance on 1995-06-02 under 510(k) number K950987. 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 STRATO/INFUSAID TUNNELER?

STRATO/INFUSAID TUNNELER is a medical device that received FDA 510(k) clearance on 1995-06-02. The listed applicant is Strato/Infusaid, Inc.. The 510(k) number is K950987.

When did STRATO/INFUSAID TUNNELER receive FDA 510(k) clearance?

STRATO/INFUSAID TUNNELER received FDA 510(k) clearance on 1995-06-02, under 510(k) number K950987.

Who is the listed applicant for STRATO/INFUSAID TUNNELER?

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

What is the FDA product code for STRATO/INFUSAID TUNNELER?

The FDA product code for STRATO/INFUSAID TUNNELER 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 Strato/Infusaid, Inc. as applicant

K960391STRATO/INFUSAID PERIPORT INFUSION SET 41770,41771 K953529STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM K954720STRATO/INFUSAIF INFUSE-A-CATH CENTRAL VENOUS CATHETERS K953254STRATO/INFUSAID INFUSE-A-KIT K953256STRATO/INFUSAID INFUS-A-CATH DUAL LUMEN PREATTACHED SILICONE CENTRAL VENOUS CATHETER SYSTEMS K953436STRATO/INFUSAID INFUSE-A-CATH SINGLE LUMEN SILICONE CENTRAL VENOUS CATHETER SYSTESM

View all 11 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.