FDA 510(k)

MAPWIRE J-TIP SENSOR GUIDEWIRE

K-Number: K952626 · 1995-08-25

Decision Date1995-08-25

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MAPWIRE J-TIP SENSOR GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Navion Biomedical Corp.. It received FDA 510(k) clearance on 1995-08-25 under 510(k) number K952626. 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 MAPWIRE J-TIP SENSOR GUIDEWIRE?

MAPWIRE J-TIP SENSOR GUIDEWIRE is a medical device that received FDA 510(k) clearance on 1995-08-25. The listed applicant is Navion Biomedical Corp.. The 510(k) number is K952626.

When did MAPWIRE J-TIP SENSOR GUIDEWIRE receive FDA 510(k) clearance?

MAPWIRE J-TIP SENSOR GUIDEWIRE received FDA 510(k) clearance on 1995-08-25, under 510(k) number K952626.

Who is the listed applicant for MAPWIRE J-TIP SENSOR GUIDEWIRE?

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

What is the FDA product code for MAPWIRE J-TIP SENSOR GUIDEWIRE?

The FDA product code for MAPWIRE J-TIP SENSOR GUIDEWIRE is LJS.

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Other records listing Navion Biomedical Corp. as applicant

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.