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510(k) Data Aggregation
K Number
K990707Device Name
MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS
Manufacturer
MEDTRONICS INTERVENTIONAL VASCULAR
Date Cleared
1999-03-22
(18 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONICS INTERVENTIONAL VASCULAR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medtronic® Zuma™ Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Zuma™ catheter is intended to be used in the coronary or peripheral vascular system.
Device Description
The Medtronic® Zuma™ Guiding Catheters will be available in 5F 9F outer diameters. The 6F and 9F (non-segmented) catheter is constructed with a braided proximal shaft with an inner liner and a soft distal tip. The 5F, 7F, 8F and 9F(segmented) Zuma catheters are manufactured with a braided proximal shaft and segments, an inner liner and a soft distal tip. The inner lumen of the Zuma™ catheter has a thin lubricious coating. The Zuma™ Guiding Catheter (6F - 9F) has a larger inner lumen diameter than its predicate devices. The 5F Zuma is comparable in stiffness to a 6F predicate device.
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K Number
K980973Device Name
MEDTRONIC ANGIOGRAPHIC CATHETER
Manufacturer
MEDTRONICS INTERVENTIONAL VASCULAR
Date Cleared
1998-12-10
(269 days)
Product Code
DQO
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONICS INTERVENTIONAL VASCULAR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medtronic® Angiographic Catheter is designed to be used for delivering radiopaque media and making pressure measurements in selected coronary sites within the vascular system.
Device Description
The Medtronic® Angiographic Catheters are 4F, 5F, 6F and 7F in diameter with a braided proximal shaft, non-braided distal segment and a variety of tip configurations.
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K Number
K982883Device Name
MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER
Manufacturer
MEDTRONICS INTERVENTIONAL VASCULAR
Date Cleared
1998-09-04
(18 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONICS INTERVENTIONAL VASCULAR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medtronice ZumaTM Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Zuma™ catheter is intended to be used in the coronary or peripheral vascular system
Device Description
The Medtronic® Zuma™ Guiding Catheters will be available in 6F, 7F and 8F outer diameters. The 6F catheter is constructed with a braided proximal shaft with an inner liner and a soft distal tip. The 7F and 8F catheters are manufactured with a braided proximal and segmented shaft with an inner liner and a soft distal tip. The inner lumen of the 22ma™ catheter (6F-8F) has a thin lubricious coating. The Zuma™ Guiding Catheter has a larger inner lumen diameter and a stiffer shaft than its predicate devices.
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K Number
K981198Device Name
MEDTRONIC ZUMA GUIDING CATHETER
Manufacturer
MEDTRONICS INTERVENTIONAL VASCULAR
Date Cleared
1998-08-07
(127 days)
Product Code
DQY, DOY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONICS INTERVENTIONAL VASCULAR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medtronic® Zuma™ Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.
Device Description
The Medtronic® Zuma™ Guiding Catheters will be available in a 6F outer diameter size. The catheter is constructed with a braided proximal shaft with an inner liner and a soft distal tip. The inner lumen of the catheter has a thin lubricious coating. The Zuma™ Guiding Catheter has a larger inner lumen diameter and a stiffer shaft.
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K Number
K972944Device Name
MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE GUIDE WIRE/STANDARD GUIDE WIRE/EXTRA SUPPORT
Manufacturer
MEDTRONICS INTERVENTIONAL VASCULAR
Date Cleared
1997-11-03
(84 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONICS INTERVENTIONAL VASCULAR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mustang™ Steerable Guide Wire is indicated for use in introducing and placing interventional catheters during percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).
Device Description
The Medtronic® MUSTANG™ Steerable Guide Wire is a quide wire having a maximum diameter of 0.014" (0.36 mm). The proximal shaft is coated with a polymer and the distal 33 cm contains a lubricious coating. The distal segment of the wire contains a spring which is radiopaque. The MUSTANG™ is provided sterile, and is intended for one procedure use only (disposable).
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K Number
K961917Device Name
MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX)
Manufacturer
MEDTRONICS INTERVENTIONAL VASCULAR
Date Cleared
1996-11-20
(187 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONICS INTERVENTIONAL VASCULAR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medtronic® MUSTANG™ Steerable Guide Wire is for use in introducing and placing interventional catheters during percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).
Device Description
The Medtronic® MUSTANG™ Steerable Guide Wire is a guide wire having a maximum diameter of 0.014" (0.36 mm). The proximal shaft is coated with a polymer and the distal 33 cm contains a lubricious coating. The distal segment of the wire contains a spring which is radiopaque. The MUSTANG™ is provided sterile, and is intended for one procedure use only (disposable).
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K Number
K960983Device Name
MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT
Manufacturer
MEDTRONICS INTERVENTIONAL VASCULAR
Date Cleared
1996-05-30
(80 days)
Product Code
MAV
Regulation Number
870.1650Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONICS INTERVENTIONAL VASCULAR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Indications for the Medtronic® Everest™ 30 Inflation Device / Survival Kit are identical to those for commercially available inflation devices. The devices are used for the inflation / deflation of balloon dilatation catheters. These devices are intended for single use.
Device Description
The Medtronic® Everest™ 30 Inflation Device is a sterilized, single use device intended as an accessory to balloon dilatation catheters. The Everest™ 30 Inflation Device will be used to inflate and deflate balloon dilatation catheters during angioplasty procedures. The device contains an analog pressure gauge which will read the inflation pressure of the balloon catheter. The pressure gauge is isolated from the syringe fluid with use of a bouron tube and is graduated in 0.5 atmosphere / bar increments to a 30 atmosphere / bar maximum. The device has a twenty (20) cubic centimeter syringe to hold a contrast medium for balloon inflation. The device has a plunger engaging mechanism. When engaged, the plunger, which applies contrast medium to the syringe, is rotated in a clockwise direction by the user to slowly increase the syringe pressure or in a counter clockwise direction to slowly decrease the syringe pressure. When disengaged, the plunger can be manually retracted to rapidly apply vacuum and advanced to rapidly apply syringe pressure. The inflation device is connected to the balloon catheter manifold via a high pressure connecting tube which terminates into a male luer fitting. The inflation device also contains an accessory three way stopcock for preparation procedures.
The inflation device may also be provided as a Survival Kit. The Survival Kit includes one (1) Y -Adapter with Hemostasis Valve, one (1) Guide Wire Introducer and one (1) Guide Wire Torque Handle.
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K Number
K955651Device Name
MEDTRONIC SHERPA GUIDING CATHETER
Manufacturer
MEDTRONICS INTERVENTIONAL VASCULAR
Date Cleared
1996-01-22
(41 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONICS INTERVENTIONAL VASCULAR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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