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FDA 510(k)

INFUSAID INFUSE-A-PORT (MODIFIED)

K-Number: K853981 · 1985-12-18

ApplicantIntermedics/Infusaid, Inc.
Decision Date1985-12-18
Product CodeLJT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFUSAID INFUSE-A-PORT (MODIFIED) is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics/Infusaid, Inc.. It received FDA 510(k) clearance on 1985-12-18 under 510(k) number K853981. 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 INFUSAID INFUSE-A-PORT (MODIFIED)?

INFUSAID INFUSE-A-PORT (MODIFIED) is a medical device that received FDA 510(k) clearance on 1985-12-18. The listed applicant is Intermedics/Infusaid, Inc.. The 510(k) number is K853981.

When did INFUSAID INFUSE-A-PORT (MODIFIED) receive FDA 510(k) clearance?

INFUSAID INFUSE-A-PORT (MODIFIED) received FDA 510(k) clearance on 1985-12-18, under 510(k) number K853981.

Who is the listed applicant for INFUSAID INFUSE-A-PORT (MODIFIED)?

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

What is the FDA product code for INFUSAID INFUSE-A-PORT (MODIFIED)?

The FDA product code for INFUSAID INFUSE-A-PORT (MODIFIED) is LJT.

Related Clinical Trials

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.

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Other records listing Intermedics/Infusaid, Inc. 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.

K863296INFUSE-A-PORT EXPLANT KITK862018MICRO PORT

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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