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FDA 510(k)

RHAPSODY CT

K-Number: K081889 · 2008-11-12

ApplicantGrantadler Corporation
Decision Date2008-11-12
Product CodeLJT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RHAPSODY CT is the device name listed in this FDA 510(k) record. The listed applicant is Grantadler Corporation. It received FDA 510(k) clearance on 2008-11-12 under 510(k) number K081889. 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 RHAPSODY CT?

RHAPSODY CT is a medical device that received FDA 510(k) clearance on 2008-11-12. The listed applicant is Grantadler Corporation. The 510(k) number is K081889.

When did RHAPSODY CT receive FDA 510(k) clearance?

RHAPSODY CT received FDA 510(k) clearance on 2008-11-12, under 510(k) number K081889.

Who is the listed applicant for RHAPSODY CT?

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

What is the FDA product code for RHAPSODY CT?

The FDA product code for RHAPSODY CT 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 Grantadler Corporation 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.

K082126RHAPSODY MRI

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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