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510(k) Data Aggregation
K Number
K034025Device Name
NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC
Manufacturer
NMT MEDICAL, INC.
Date Cleared
2004-03-26
(88 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
NMT MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NMT Medical Transseptal Sheath Set is indicated for percutaneous introduction of various cardiovascular devices into the left side of the hear through the atrial septum.
Device Description
The NMT Medical Transseptal Sheath Set consists of a long and short introducer sheath set. The long sheath set is comprised of a curved 75cm length introducer sheath and curved 81 cm length dilator. The short sheath set is comprised of a straight 12cm length introducer sheath and straight 19cm length dilator.
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K Number
K994191Device Name
SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T
Manufacturer
NMT MEDICAL, INC.
Date Cleared
2000-02-08
(57 days)
Product Code
HCI
Regulation Number
882.4175Why did this record match?
Applicant Name (Manufacturer) :
NMT MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications for and intended use of the aneurysm clip applier is to hold and sufficiently open the aneurysm clip for application during intracranial aneurysm repair surgery. The device is used to deliver the aneurysm clip to the site of the intracranial aneurysm.
The Spetzler™ Round-Handled Applier is designed for use only with the Spetzler™ Titanium Aneurysm Clips.
Device Description
There are two types of Spetzler™ Round Handle Appliers; Stainless Steel with Titanium Jaws and Pads and completely Titanium. Each type applier has two styles; straight and bayonet.
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