FDA 510(k)

LIFEPORT POLYURETHANE CATHETER

K-Number: K895871 · 1989-11-17

Decision Date1989-11-17

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

LIFEPORT POLYURETHANE 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 1989-11-17 under 510(k) number K895871. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFEPORT POLYURETHANE CATHETER?

LIFEPORT POLYURETHANE CATHETER is a medical device that received FDA 510(k) clearance on 1989-11-17. The listed applicant is Strato Medical Corp.. The 510(k) number is K895871.

When did LIFEPORT POLYURETHANE CATHETER receive FDA 510(k) clearance?

LIFEPORT POLYURETHANE CATHETER received FDA 510(k) clearance on 1989-11-17, under 510(k) number K895871.

Who is the listed applicant for LIFEPORT POLYURETHANE 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 LIFEPORT POLYURETHANE CATHETER?

The FDA product code for LIFEPORT POLYURETHANE CATHETER is LJT.

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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: LJT)

K260916FLEXI-PORT™ Power Injectable Implantable PortPortal Access, Inc.K252478Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable PortBard Access Systems, Inc.K251253PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable PortBard Access Systems, Inc.K242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable PortsBard Access Systems, Inc.K232737PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable Port; PowerPort™ isp M.R.I.™ ECG Enabled Implantable Port; PowerPort™ Slim ECG Enabled Implantable PortBard Peripheral Vascular, Inc.K190559SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsAngioDynamics, 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.