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Devices
Device Recall AngioSculpt PTA Scoring Balloon Catheter
Model / Serial
Part (REF) number: 2076-5020: All lot codes
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: USA, China, Finland, Italy, Japan, Norway, Saudi Arabia, Spain, Sweden, Switzerland, UAE, United Kingdom
Product Description
AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 5.0 mm x 20 mm balloon size, Part (REF) number: 2076-5020.
Manufacturer
AngioScore Inc.
1 Event
Recall of Device Recall AngioSculpt PTA Scoring Balloon Catheter
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Manufacturer
AngioScore Inc.
Manufacturer Address
AngioScore Inc., 5055 Brandin Ct, Fremont CA 94538-3140
Manufacturer Parent Company (2017)
Philips
Source
USFDA
4 devices with a similar name
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Device Recall AngioSculpt PTA Scoring Balloon Catheter
Model / Serial
Part (REF) number: 2076-6020: All lot codes
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: USA, China, Finland, Italy, Japan, Norway, Saudi Arabia, Spain, Sweden, Switzerland, UAE, United Kingdom
Product Description
AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 6.0 mm x 20 mm balloon size, Part (REF) number: 2076-6020.
Manufacturer
AngioScore Inc.
Device Recall AngioSculpt PTA Scoring Balloon Catheter
Model / Serial
Part (REF) number: 2092-6020: All lot codes
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: USA, China, Finland, Italy, Japan, Norway, Saudi Arabia, Spain, Sweden, Switzerland, UAE, United Kingdom
Product Description
AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 90 cm, 6.0mm x 20 mm balloon size, Part (REF) number: 2092-6020.
Manufacturer
AngioScore Inc.
Device Recall AngioSculpt PTA Scoring Balloon Catheter
Model / Serial
Part (REF) number: 2105-6020: All lot codes
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: USA, China, Finland, Italy, Japan, Norway, Saudi Arabia, Spain, Sweden, Switzerland, UAE, United Kingdom
Product Description
AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 50 cm, 6.0mm x 20 mm balloon size, Part (REF) number: 2105-6020
Manufacturer
AngioScore Inc.
Device Recall AngioSculpt PTA Scoring Balloon Catheter
Model / Serial
Part (REF) number: 2076-4020: All lot codes
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: USA, China, Finland, Italy, Japan, Norway, Saudi Arabia, Spain, Sweden, Switzerland, UAE, United Kingdom
Product Description
AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; || OTW 0.018" Platform, 137 cm, 4.0 mm x 20 mm balloon size. Part (REF) number: 2076-4020
Manufacturer
AngioScore Inc.
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