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510(k) Data Aggregation
K Number
K082126Device Name
RHAPSODY MRI
Manufacturer
Date Cleared
2008-11-13
(107 days)
Product Code
Regulation Number
880.5965Why did this record match?
Applicant Name (Manufacturer) :
GRANTADLER CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The grantAdler Rhapsody Access Port and Catheter is indicated for any patient requiring reliable repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products or the sampling of blood. The Rhapsody Port and Catheter are safe to use in an MRI environment.
Device Description
grantAdler Ports and Catheters are supplied as sterile devices, and are intended for single patient use only. The ports are available as a single model and are manufactured of the highest quality titanium. They also incorporate a durable high compression self-sealing silicone septum. Catheter materials include flexible, non-compressible, and reinforced silicone. Suture sites are incorporated into the port base to facilitate anchorage to the underlying fascia. The grantAdler port line is indicated for any patient requiring reliable repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products, or the sampling of blood.
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K Number
K081889Device Name
RHAPSODY CT
Manufacturer
Date Cleared
2008-11-12
(133 days)
Product Code
Regulation Number
880.5965Why did this record match?
Applicant Name (Manufacturer) :
GRANTADLER CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Grant Adler Rhapsody port line is intended to facilitate reliable and repeated acces of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products or the sampling of blood. Access is performed by percutaneous needle insertion, using only non-coring, Huber needles. When used with a power injectable needle, Rhapsody CT is indicated for power injection of contrast media. For power injection of contrast media, the maxum recommended infusion rate is 5 ml/s with a 19 or 20 gauge non-coring power injectable needle and 2 ml/s with 22 gauge non-coring power injectable needle. The Rhapsody CT has been tested and is conditionally safe to use in an MRI environment up to 3T. The Port is normally included in a Convenience Kit which will be used for the procedure. The GrantAdler Convenience Kit includes all cleared or exempt devices.
Device Description
The Rhapsody CT is supplied as a sterile device, and is intended for single patient use only. The port is available as a single model and is manufactured of the highest quality titanium. It also incorporates a durable high compression self-sealing silicone septum. Catheter materials include flexible, non-compressible, and reinforced silicone. The Port is normally inclused in a Convenience Kit which will be used for the procedure. The GrantAdler Convenience Kit includes all cleared or exempt devices.
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