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Ultrascore™ Not Applicable Ultrascore™ Focused Force PTA Balloon

Ultrascore™ Focused Force PTA Balloon

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1.844.8.BD.LIFE (1.844.823.5433)
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1.844.8.BD.LIFE (1.844.823.5433)
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850 W Rio Salado Pkwy, Tempe, AZ 85281 United States
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1.844.8.BD.LIFE (1.844.823.5433)
6:00 a.m. – 4:30 p.m. Arizona Time (Monday-Friday)
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1.800.440.5376
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Overview
  • Specialty Scoring Balloon
  • Focused Force Dilatation
  • Low Profile, Over-the-Wire Design
  • 2 Longitudinal .010″ wires placed 180 degrees apart
  • .014″ & .035″ Compatible
  • Broadest Scoring Balloon Portfolio (up to 300mm)2
  • GeoAlign™ Marking System

 

The UltraScore™ Balloon is the first commercially available .035” scoring balloon, with sizes available on both .014” and .035” guidewire platforms.

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Features and Benefits
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References

1. Based on theoretical calculation using equation P=F/A comparing UltraScore™ Balloon to POBA. Data on File, Bard Peripheral Vascular, Inc., Tempe, AZ. May not be predictive of clinical performance. Different tests may yield different results.
2. As of January 2022.
3. When the catheter is introduced to the vascular system, the location of balloon should be confirmed while under fluoroscopic observation. GeoAlign™ Markers are not a replacement for fluoroscopy. Animal study (repeat PTA in swine artery) was performed by 3 physicians who tested the Lutonix™ 035 (no drug) and the Ultraverse® 035 pta Catheter, both with GeoAlign™ Markers, to POBA with no GeoAlign™ Markers(n=112, test n=96 (average placement time of 66 seconds), control n=16 (average placement of 90 seconds)). Animal data on file, Bard Peripheral Vascular, Inc. Tempe, AZ. Animal test results may not be indicative of clinical performance. Different test methods may yield different results.
4. Compared to all other scoring balloons on the U.S. Market
5. Not all diameters available in every length

Please consult Instructions for Use under Resources for product indications for use, contraindications, warnings, precautions, complications, adverse events and detailed safety information.

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Specification

GTIN - each

00801741116735

1


Wire Compatibility

0.035"

Balloon Diameter

5 mm

Balloon Length

20 mm

Catheter Length

130 cm

French Size

5F

GTIN

GTIN - each 00801741116735 1

Product Basic Specification

Wire Compatibility 0.035"
Balloon Diameter 5 mm
Balloon Length 20 mm
Catheter Length 130 cm
French Size 5F
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Resources
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RELATED PRODUCTS NOT AVAILABLE
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Product Complaints
North American Regional Complaint Center
1-844-8BD-LIFE (1-844-823-5433)
Things to Consider

If you are a patient or end user, you can contact us yourself, or you may have your caregiver or your physician do that for you. To help us process your
information quickly and effectively, please contact our customer complaints
team.

To better facilitate our investigation, please include the following information in your reporting:


  • Product Name and/or Catalog Number
  • Lot Number or Serial Number
  • Any injuries and/or Harm?
  • What is the issue you experienced?
  • Is the actual sample or sample representative available? (If possible, please send affected sample)
  • Contact name and phone number
Product Recalls
Recall Notifications
These recall notices provide current information on medical device recalls.
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