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510(k) Data Aggregation
K Number
K983297Device Name
MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM WITH SLOW RELEASE
Manufacturer
Date Cleared
1998-12-18
(88 days)
Product Code
Regulation Number
878.3610Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONIC INSTENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Medtronic InStent EsophaCoil Esophageal Stent System with Slow Release in indicated for use in the treatment of esophageal obstructions produced by malignant neoplasms.
Device Description
The Medtronic InStent EsophaCoil Esophageal Stent System with Slow Release is self-expandable metal stent which is mounted on a delivery catheter. The stent is manufactured from a nickel titanium (Nitinol) material and is comprised of a center stenting section of adjacent coils and two flared ends which enhance fixation. The delivery catheter is manufactured from a thermoplastic material with a tapered end and flexible tip. The stent is wound in a reduced diameter configuration and held in place by a restraining means. The restraining means in connected to the "slow release" handle on the proximal end of the catheter. The slow release allows the stent to be released from the catheter in a fixed and controlled speed manner.
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