(224 days)
The Bard Memotherm Transhepatic Biliary Endoprosthesis is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms.
The Bard Memotherm Transhepatic Endoprosthesis is a stenting device designed to maintain the patency of biliary ducts obstructed by malignant neoplasms. The device includes the self-expanding Bard Memotherm Transhepatic Biliary Endoprosthesis pre-loaded on a unique delivery system. This 7 Fr. delivery system is compatible with a 7 Fr. introducer and accepts a .035" guidewire. The Bard Memotherm Transhepatic Biliary Endoprosthesis is available in various diameters and lengths. The Bard Memotherm Transhepatic Biliary Endoprosthesis is a metal mesh stent constructed of biocompatible nitinol. It is self-expanding and is packaged pre-mounted on a disposable delivery system. It will be available in expanded diameters of 7, 8, 9, 10 and 12mm and in lengths from 30mm to 110mm.
The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. It describes the device, its intended use, and general performance characteristics but lacks specific quantitative acceptance criteria or detailed study methodologies, sample sizes, ground truth establishment, or expert involvement.
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IRANIRO
111
MAY - 2 1997
SECTION VI
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
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A. Submitter Information:
Submitter's Name: C. R. Bard, Inc., Radiology Division Submitter's Address: 13183 Harland Drive., Covington, GA 30209 Contact Person: Donna J. Wilson Contact Person's Address: 8195 Industrial Blvd., Covington, GA 30209 Contact Person's Telephone Number: 770-784-6135 Contact Person's FAX Number 770-784-6419 Date of Preparation: September 16, 1996 -
B. Device Name:
Bard® Memotherm® Transhepatic Biliary Endoprosthesis -
C. Predicate Device Name:
Schneider Wallstent -
D. Device Description
The Bard Memotherm Transhepatic Endoprosthesis is a stenting device designed to maintain the patency of biliary ducts obstructed by malignant neoplasms. The device includes the self-expanding Bard Memotherm Transhepatic Biliary Endoprosthesis pre-loaded on a unique delivery system. This 7 Fr. delivery system is compatible with a 7 Fr. introducer and accepts a .035" guidewire. The Bard Memotherm Transhepatic Biliary Endoprosthesis is available in various diameters and lengths.
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z (1)
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E. Intended Use:
The Bard Memotherm Transhepatic Biliary Endoprosthesis is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms. -
F. Technological Characteristics Summary:
The Bard Memotherm Transhepatic Biliary Endoprosthesis is a metal mesh stent constructed of biocompatible nitinol. It is self-expanding and is packaged pre-mounted on a disposable delivery system. It will be available in expanded diameters of 7, 8, 9, 10 and 12mm and in lengths from 30mm to 110mm.
G. Performance Data:
The Bard Memotherm Transhepatic Biliary Endoprosthesis deploys easily from the delivery system even in a tortuous path. The delivery system withstands pull test forces in excess of 5 lbs for the shaft-tohandle joint and in excess of 2 lbs for the tip-to-shaft joint. Elastic properties of the Memotherm stent are comparable to those for the The stent is resistant to corrosion by bile and to predicate device. compressive forces expected to be encountered within the biliary system.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.