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Found 9 results
510(k) Data Aggregation
K Number
K073664Device Name
FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER
Manufacturer
INJECTIMED, INC.
Date Cleared
2008-08-08
(226 days)
Product Code
MDM
Regulation Number
878.4800Why did this record match?
Product Code :
MDM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A percutaneous guide wire introducer for vascular and non-vascular procedures with activating safety shield to reduce needle stick injury during use and disposal.
Device Description
A needle and hub device for the percutaneous introduction of a guide wire, with a hub modification to allow one-handed activation of a sheath to cover the needle and help prevent accidental needle sticks during use and disposal.
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K Number
K050575Device Name
FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM
Manufacturer
FUTUMEDS SDN BHD
Date Cleared
2005-08-15
(161 days)
Product Code
MDM
Regulation Number
878.4800Why did this record match?
Product Code :
MDM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended to pierce the epidermal layer of the human skin for the collection of a small volume of blood sample.
Device Description
Not Found
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K Number
K050957Device Name
EUTROCHAR
Manufacturer
SPECIAL DEVICES, INC.
Date Cleared
2005-05-18
(33 days)
Product Code
MDM
Regulation Number
878.4800Why did this record match?
Product Code :
MDM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FOR USE IN INSTALLING SURGICAL DRAINS
Device Description
The EuTrochar is a trocar used for the installation of surgical drains. The EuTrochar has a handle, the "Deployer" to facilitate gripping, to improve accuracy of drain placement and to keep fingers away from the sharp point. Trocars have been used for more than a hundred years to create an incision in soft tissue for surgical drain tubing. Like other drain installation trocars, this instrument is a highly polished stainless steel rod of small diameter, normally 4 to 6mm in diameter and about 160mm long. One end of the rod is very sharply pointed and the other end has a hose barb for affixing tying. The rod is curved between the two ends so that it looks like a giant sailmaker's needle.
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K Number
K023173Device Name
ANDREWS INTRODUCER, MODEL ASI01
Manufacturer
ANDREWS SURGICAL INNOVATIONS, LTD.
Date Cleared
2002-12-18
(86 days)
Product Code
MDM
Regulation Number
878.4800Why did this record match?
Product Code :
MDM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Andrews Introducer™ is specifically designed for the insertion of intercostal chest tubes.
Device Description
The Andrews Introducer™ is a reusable surgical forceps made of surgical steel that is specifically designed for the insertion of chest tubes. The Andrews Introducer™ is a three-limbed forceps and has three major features:
1. A pivot joint at the fulcrum that opens the tips when the handles are closed using the stronger gripping force of the hand. The extent to which the tips open has been limited so as to reduce the trauma to the intercostal muscle.
2. A vertical extension on each blade that creates a circular channel which is more accurately and appropriately shaped to allow easy passage of the chest tube. The distance between the vertical blades at the fulcrum is 10.7 millimetres, sufficient-to accommodate the diameter of a 32 gauge chest tube, expanding to 22mm at the.
3. A third limb that is attached to the two main limbs through the pivot joint. It is held equidistant from the two main limbs by two leaf springs, which also close the tips when force is relieved from the handles. There is also a grip on the distal end of the third limb to hold the chest tube in position on the instrument for more rapid insertion once the channel has been created.
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K Number
K022059Device Name
MICROVASIVE PULMONARY GUIDEWIRE
Manufacturer
BOSTON SCIENTIFIC CORP.
Date Cleared
2002-11-13
(141 days)
Product Code
MDM
Regulation Number
878.4800Why did this record match?
Product Code :
MDM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pulmonary Guidewire is indicated for use to provide access to the tracheobronchial tree.
Device Description
The Pulmonary Guidewire is constructed of a core wire, outer jacket and a tip. The guidewire is designed to provide access to the tracheobronchial tree.
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K Number
K013040Device Name
LIGHT SABER INTRODUCER NEEDLE
Manufacturer
MINRAD, INC.
Date Cleared
2001-12-07
(88 days)
Product Code
MDM, FMF
Regulation Number
878.4800Why did this record match?
Product Code :
MDM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended Use: A single use disposable introducer needle/cannula intended for A single use disposuble wires in non-vascular procedures.
Indications for Use: For use with the Dual Radiation Targeting System (ie: DRTS) to improve the accuracy of the needle placement.
Device Description
The Light Saber Introducer Needle consists of a needle, a collimator, to which The fight Saber Introducer Neves enclosed in a cannula/hub assembly with a a soyieving tip. The female Luer of the cannula hub, for attachment to the mateling op. The 10to comply with ISO-594 for "Conical fittings with a 6% Syringe, is debigited to ossings of ther medical equipment." The Light (Duer) tor by inges) installer are provided in gauges of 17, 18, and 19 and in Daber - Invodated 11 Sinches. The tip design for these needles will provide icities of 27x, I all a point. Depth markings are standard on the cannula at 1cm intervals.
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K Number
K010184Device Name
CHESS HAND SURGERY SYSTEM
Manufacturer
CANICA DESIGN, INC.
Date Cleared
2001-06-22
(154 days)
Product Code
MDM
Regulation Number
878.4800Why did this record match?
Product Code :
MDM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K990062Device Name
SAPHLIFT
Manufacturer
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
Date Cleared
1999-03-30
(81 days)
Product Code
MDM, MDW
Regulation Number
878.4800Why did this record match?
Product Code :
MDM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SAPHLIFT is a holding and manipulating arm for use in surgery which allows the operating team to hold surgical instruments in a given position and to change that position immediately with one hand.
The SAPHLIFT is a holding and manipulating arm for use in surgery which allows the operating team to hold manual surgical instruments and the SaphLite Retractor in a given position and to change that position immediately with one hand.
Device Description
The SAPHLIFT consists of three main components: an articulated arm that clamps to the rail of the surgical bed, an instrument holder, and a compressed gas supply to maintain the pneumatic pressure to hold the instrument in place. Ball joints in the articulated arm and instrument holder allow for a wide variety of instrument positions. Repositioning of the instrument is by means of a control lever that releases the pneumatic pressure when pressed and locks the instrument in place when released. The SAPHLIFT is reusable and is sterilized by steam autoclave.
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K Number
K981579Device Name
ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG
Manufacturer
ETHICON, INC.
Date Cleared
1998-07-09
(66 days)
Product Code
MDM
Regulation Number
878.4800Why did this record match?
Product Code :
MDM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ENDOPOUCH PRO Specimen Retrieval Bag is intended for use during general laparoscopic surgical procedures as well as the collection and extraction of tissue specimens such as the appendix, gall bladder, ovaries, fibroid tumors, other tissues and calculi.
ENDOPOUCH PRO Specimen Retrieval Bag is a disposable device used as a receptacle for the collection and extraction of tissue specimens such as the appendix, gall bladder, ovaries, fibroid tumors, other tissues and calculi during laparoscopic surgical procedures.
Device Description
The ENDOPOUCH PRO device is comprised of a flexible plastic bag with a large, easily accessible opening, a push rod handle and an introducer tube. The push rod and handle allow for single hand deployment.
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