FDA 510(k)

STRATO LIFE PORT II DUAL LUMEN PORT/MODIFICATION

K-Number: K905847 · 1991-04-05

Decision Date1991-04-05

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

STRATO LIFE PORT II DUAL LUMEN PORT/MODIFICATION 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 1991-04-05 under 510(k) number K905847. 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 STRATO LIFE PORT II DUAL LUMEN PORT/MODIFICATION?

STRATO LIFE PORT II DUAL LUMEN PORT/MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-04-05. The listed applicant is Strato Medical Corp.. The 510(k) number is K905847.

When did STRATO LIFE PORT II DUAL LUMEN PORT/MODIFICATION receive FDA 510(k) clearance?

STRATO LIFE PORT II DUAL LUMEN PORT/MODIFICATION received FDA 510(k) clearance on 1991-04-05, under 510(k) number K905847.

Who is the listed applicant for STRATO LIFE PORT II DUAL LUMEN PORT/MODIFICATION?

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 LIFE PORT II DUAL LUMEN PORT/MODIFICATION?

The FDA product code for STRATO LIFE PORT II DUAL LUMEN PORT/MODIFICATION 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.