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FDA 510(k)

LPP (LOW PROFILE PORT)

K-Number: K122402 · 2013-07-16

ApplicantPfm Medical, Inc.
Decision Date2013-07-16
Product CodeLJT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LPP (LOW PROFILE PORT) is the device name listed in this FDA 510(k) record. The listed applicant is Pfm Medical, Inc.. It received FDA 510(k) clearance on 2013-07-16 under 510(k) number K122402. 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 LPP (LOW PROFILE PORT)?

LPP (LOW PROFILE PORT) is a medical device that received FDA 510(k) clearance on 2013-07-16. The listed applicant is Pfm Medical, Inc.. The 510(k) number is K122402.

When did LPP (LOW PROFILE PORT) receive FDA 510(k) clearance?

LPP (LOW PROFILE PORT) received FDA 510(k) clearance on 2013-07-16, under 510(k) number K122402.

Who is the listed applicant for LPP (LOW PROFILE PORT)?

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

What is the FDA product code for LPP (LOW PROFILE PORT)?

The FDA product code for LPP (LOW PROFILE PORT) is LJT.

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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

View on FDA Database →

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

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