FDA.reportPublic FDA data

PROTEUS

Primary DI
07290014582033
Brand
PROTEUS
Company
ANGIOSLIDE LTD
Model
1U-0660-135-03
Catalog number
1U-0660-135-03
Device description
PROTEUS PTA Catheter with Embolic Capture Feature 6x60mm
Published
2017-12-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous
LITCatheter, Angioplasty, Peripheral, Transluminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
LITCatheter, Angioplasty, Peripheral, TransluminalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172494000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172494000PROTEUS PTA Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.2017-12-15LIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290014582033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290014582033072900145820337290014582033

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral angioplasty balloon catheter, basicA sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include microsurgical blades (atherotomes) to score the plaque. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+972523265853anatk@angioslide.com

Regulatory Flags#

DUNS number
514451397
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290014582002PROTEUS1U-5100-135-031U-5100-135-032016-11-21
07290014582019PROTEUS1U-0560-135-031U-0560-135-032017-01-29
07290014582026PROTEUS1U-6100-135-031U-6100-135-032017-12-21
07290014582071PROTEUS1U-0420-135-031U-0420-135-032017-08-30
07290014582088PROTEUS1U-0440-135-021U-0440-135-022017-08-30
07290014582095PROTEUS1U-0480-135-021U-0480-135-022017-08-30
07290014582101PROTEUS1U-0520-135-021U-0520-135-022017-08-30
07290014582118PROTEUS1U-0540-135-041U-0540-135-042017-08-30
07290014582132PROTEUS1U-0620-135-021U-0620-135-022017-08-30
07290014582149PROTEUS1U-0640-135-021U-0640-135-022017-08-30
07290014582163PROTEUS1U-3100-135-021U-3100-135-022017-08-30
07290014582170PROTEUS1U-0460-135-021U-0460-135-022017-08-30
07290014582187PROTEUS1U-4100-135-021U-4100-135-022017-08-30

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