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FDA 510(k)

STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMS

K-Number: K946250 · 1995-05-02

ApplicantStrato Medical Corp.
Decision Date1995-05-02
Product CodeLJS
Advisory CommitteeHO
DecisionUnknown

Device Summary

STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Strato Medical Corp.. It received FDA 510(k) clearance on 1995-05-02 under 510(k) number K946250. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMS?

STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMS is a medical device that received FDA 510(k) clearance on 1995-05-02. The listed applicant is Strato Medical Corp.. The 510(k) number is K946250.

When did STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMS receive FDA 510(k) clearance?

STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMS received FDA 510(k) clearance on 1995-05-02, under 510(k) number K946250.

Who is the listed applicant for STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMS?

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

What is the FDA product code for STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMS?

The FDA product code for STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMS is LJS.

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Other records listing Strato Medical Corp. as applicant

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K945956STRATO MEDICAL INFUSE-A-CATH TRIPLE LUMEN SILICONE CATHETER SYSTEMSK942848STRATO MEDICAL LIFEPORT LPS 7515K934518STRATO MEDICAL INFUSE-A-PORT/INFUSE-A-KIT PERIPORT PERIPHERAL ACCESS SYSTEMK932509STRATO MEDICAL INFUSE-A-PORT/SNAP-LOCK MACROPRORTK933884STRATO MEDICAL LIFEPORT LPS 7255 LOW PROFILE DUAL LUMEN VASCULAR ACCESS SYSTEMK924851STRATO MEDICAL SINGLE LUMEN VALVED CATHETER

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Related Devices (Code: LJS)

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.

K260929Neonav ECG Tip Location SystemNavi Medical TechnologiesK252373BioFlo 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 VascularK252792PM2™ 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.

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