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Found 38 results
510(k) Data Aggregation
K Number
K211910Device Name
Z-6 Atrioseptostomy Catheter
Manufacturer
NuMED, Inc.
Date Cleared
2021-07-19
(28 days)
Product Code
DXF
Regulation Number
870.5175Why did this record match?
Applicant Name (Manufacturer) :
NuMED, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Recommended for balloon atrioseptostomy, an accepted technique in most pediatric cardiology centers for the palliation of several congenital cardiac defects. Balloon atrioseptostomy is performed in conjunction with diagnostic cardiac catheterization and has been carried out after the diagnosis of several congenital cardiac defects: transposition of the great arteries, total anomalous pulmonary venous drainout pulmonary obstruction, tricuspid atresia, mitral stenosis, mitral atresia, and pulmonary atresia with intact ventricular septum.
Device Description
Not Found
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K Number
K211134Device Name
BIB Stent Placement Catheter
Manufacturer
NuMED, Inc
Date Cleared
2021-05-27
(41 days)
Product Code
NVM
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
NuMED, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated for CP Stent / Covered CP Stent placement in vessels over 8mm in diameter.
Device Description
Not Found
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K Number
K190974Device Name
D'Vill Introducer
Manufacturer
NuMED, Inc.
Date Cleared
2019-05-14
(29 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
NuMED, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Recommended for introduction of balloons, catheters and other diagnostic and interventional devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
Device Description
The NuMED D'VILL Introducer is recommended for introduction of balloons, catheters and other diagnostic and interventional devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The introducer consists of a dilator and sheath with hemostasis valve and side port on the proximal end of the sheath assembly. There is a single image band embedded in the distal end of the sheath tubing for imaging purposes. The sheath is Pebax braided with stainless steel and a PTFE liner and will accommodate a 0.035" guidewire. The dilator is LDPE. The D'VILL is available in 10, 12 and 14F sizes in both 30 and 85cm lengths, as well as, 12 and 14F in a 65 cm length.
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K Number
K171206Device Name
D'Vill Introducer
Manufacturer
NuMED, Inc.
Date Cleared
2017-10-20
(178 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
NuMED, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Recommended for introduction of balloons, catheters and other diagnostic and interventional devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
Device Description
The NuMED D'VILL Introducer is recommended for introduction of balloons, catheters and other diagnostic and interventional devices. The introducer consists of a dilator, and sheath with hemostasis valve and side port on the proximal end of the sheath assembly. There is a single image band embedded in the distal end of the sheath tubing for imaging purposes. The sheath is Pebax braided with stainless steel and a PTFE liner and will accommodate a 0.035" guidewire. The dilator is LDPE. The D'VILL is available in 10, 12 and 14F sizes and 30 and 85cm lengths.
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K Number
K161451Device Name
BIB Stent Placement Catheter
Manufacturer
NUMED, INC.
Date Cleared
2016-09-22
(119 days)
Product Code
NVM
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
NUMED, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BIB Stent Placement Catheter
Device Description
Not Found
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K Number
K160598Device Name
REBOA Balloon Catheter
Manufacturer
NUMED, INC.
Date Cleared
2016-06-20
(110 days)
Product Code
MJN
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
NUMED, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Recommended for temporary occlusion of the aorta.
Device Description
The REBOA Balloon Occlusion Catheter is a coaxial catheter recommended for temporary occlusion of the aorta. The outer body is made of polymeric tubing, and the inner tubing is comprised of a multi-layer extrusion of polyamide (Vestamid PA12) that surrounds a braid of 304 LV Stainless Steel. The catheter features a proximal end bifurcate with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon. This balloon is of the non-compliant variety and is designed to insert through the smallest possible introduction sleeve. The through lumen terminates at the tip of the catheter, and will accept the passage of the appropriate guidewire. All catheter sizes will have radiopaque platinum marker band(s), centered or under the balloon shoulders, for placement using fluoroscopy. There are also markings on the catheter shaft to aid in placement. The catheter is packaged in a polyethylene loop and is double packed in two heat sealed Tyvek pouches.
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K Number
K160889Device Name
BIB Stent Placement Catheter
Manufacturer
NUMED, INC.
Date Cleared
2016-05-20
(50 days)
Product Code
NVM
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
NUMED, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated for CP Stent / Covered CP Stent placement in vessels over 8mm in diameter.
Device Description
The NuMED BIB® Stent Placement Catheter Model 420 is indicated for CP Stent / Covered CP Stent placement in vessels over 8mm in diameter. The catheter is triaxial in construction with two lumens being used to inflate the balloons while one lumen is being used for tracking over a guidewire. The purpose of the double balloon catheter is to apply an incremental inflation for the purpose of dilating a stent. The inner balloon provides initial expansion of the stent and also acts as a tool to hold the stent on the catheter prior to the outer balloon being inflated. The outer balloon is then inflated providing the remainder of the expansion. There are radiopaque platinum marker bands under the balloon shoulders for placement using fluoroscopy. The balloon material is clear. The catheter balloon diameters are stamped onto the inflation extensions and are labeled with balloon diameter x balloon length and the catheter lot number.
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K Number
K131869Device Name
PTS-X SIZING BALLOON CATHETER
Manufacturer
NUMED, INC.
Date Cleared
2013-08-08
(45 days)
Product Code
MJN
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
NUMED, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K122012Device Name
Z-MED Z-MED II
Manufacturer
NUMED, INC.
Date Cleared
2012-10-04
(86 days)
Product Code
OZT
Regulation Number
870.1255Why did this record match?
Applicant Name (Manufacturer) :
NUMED, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Balloon Aortic Valvuloplasty
Device Description
The NuMED Z-MED™ catheter is a coaxial catheter recommended for Balloon Aortic Valvuloplasty. The catheter's inner and outer shafts are constructed of polyamide tubing. The catheter features a molded proximal end bifurcate with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon made of polyamide. This balloon is of the non-compliant variety. Both the shaft size and the guidewire size vary according to balloon diameter. The distal lumen terminates at the tip of the catheter and will accept the passage of the appropriate guidewire. The lumen has radiopaque platinum marker band(s), centered or under the balloon shoulders, for placement using fluoroscopy. The catheter is white in color and the balloon material is clear. The catheter balloon diameter and name is stamped onto the Y sleeve and the balloon extension is labeled with the catheter specifications and lot number. The catheter is packaged in a polyethylene sheath and is double packed in two heat sealed Tyvek pouches. The NuMED Z-MED II™ catheter is a coaxial catheter recommended for Balloon Aortic Valvuloplasty. The catheter's inner and outer shafts are constructed of polyamide tubing. The catheter features a molded proximal end bifurcate with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon made of polyamide. This balloon is of the non-compliant variety. Both the shaft size and the guidewire size vary according to balloon diameter. The distal lumen terminates at the tip of the catheter and will accept the passage of the appropriate guidewire. The lumen has radiopaque platinum marker band(s), centered or under the balloon shoulders, for placement using fluoroscopy. The catheter is white in color and the balloon material is clear. The catheter balloon diameter and name is stamped onto the Y sleeve and the balloon extension is labeled with the catheter specifications and lot number. The catheter is packaged in a polyethylene sheath and is double packed in two heat sealed Tyvek pouches.
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K Number
K121859Device Name
TYSHAK NUCLEUS
Manufacturer
NUMED, INC.
Date Cleared
2012-08-31
(66 days)
Product Code
DQY, DOY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
NUMED, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.
- A patient with isolated pulmonary stenosis.
- A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.
Device Description
Not Found
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