FDA 510(k)

STRATO INDWELLING CATHETER

K-Number: K896598 · 1990-04-25

Decision Date1990-04-25

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

STRATO INDWELLING CATHETER 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 1990-04-25 under 510(k) number K896598. 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 INDWELLING CATHETER?

STRATO INDWELLING CATHETER is a medical device that received FDA 510(k) clearance on 1990-04-25. The listed applicant is Strato Medical Corp.. The 510(k) number is K896598.

When did STRATO INDWELLING CATHETER receive FDA 510(k) clearance?

STRATO INDWELLING CATHETER received FDA 510(k) clearance on 1990-04-25, under 510(k) number K896598.

Who is the listed applicant for STRATO INDWELLING CATHETER?

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 INDWELLING CATHETER?

The FDA product code for STRATO INDWELLING CATHETER is LJS.

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Other records listing Strato Medical Corp. as applicant

K945956STRATO MEDICAL INFUSE-A-CATH TRIPLE LUMEN SILICONE CATHETER SYSTEMS K946250STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMS K942848STRATO MEDICAL LIFEPORT LPS 7515 K934518STRATO MEDICAL INFUSE-A-PORT/INFUSE-A-KIT PERIPORT PERIPHERAL ACCESS SYSTEM K932509STRATO MEDICAL INFUSE-A-PORT/SNAP-LOCK MACROPRORT K933884STRATO MEDICAL LIFEPORT LPS 7255 LOW PROFILE DUAL LUMEN VASCULAR ACCESS SYSTEM

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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.