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FDA 510(k)

POLYSITE IMPLANTABLE INFUSION PORTS

K-Number: K122834 · 2013-12-11

ApplicantPerouse Medical
Decision Date2013-12-11
Product CodeLJT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POLYSITE IMPLANTABLE INFUSION PORTS is the device name listed in this FDA 510(k) record. The listed applicant is Perouse Medical. It received FDA 510(k) clearance on 2013-12-11 under 510(k) number K122834. 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 POLYSITE IMPLANTABLE INFUSION PORTS?

POLYSITE IMPLANTABLE INFUSION PORTS is a medical device that received FDA 510(k) clearance on 2013-12-11. The listed applicant is Perouse Medical. The 510(k) number is K122834.

When did POLYSITE IMPLANTABLE INFUSION PORTS receive FDA 510(k) clearance?

POLYSITE IMPLANTABLE INFUSION PORTS received FDA 510(k) clearance on 2013-12-11, under 510(k) number K122834.

Who is the listed applicant for POLYSITE IMPLANTABLE INFUSION PORTS?

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

What is the FDA product code for POLYSITE IMPLANTABLE INFUSION PORTS?

The FDA product code for POLYSITE IMPLANTABLE INFUSION PORTS is LJT.

Related Clinical Trials

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Other records listing Perouse Medical as applicant

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.

K123035SEAL ONEK120261PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBER

Related Devices (Code: LJT)

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.

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.

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