SABERX .014 PTA Dilatation Catheter

Primary DI
20705032089552
Brand
SABERX .014 PTA Dilatation Catheter
Company
Cordis US Corp.
Model
47560120L
Catalog number
47560120L
Device description
PTA, RX, 6.0 x 120, 200cm
Published
2023-07-05
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

Product Codes#

Code, Name table
CodeName
LITCatheter, angioplasty, peripheral, transluminal

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221832000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221832000SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation CatheterCordis US Corp2022-08-22LIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705032089552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503208955220705032089552

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 cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118274128
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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10705032100953VISTA BRITE TIP778-270-00M778-270-00M2024-09-09
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10862028000427MYNX CONTROLMX5060MX50602018-10-22
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10705032009898AVANTI504604A504604A2016-08-01
10705032009904AVANTI504604P504604P2016-08-01
10705032009911AVANTI504604S504604S2016-08-01
10705032009935AVANTI504604X504604X2016-08-01
10705032009942AVANTI504605A504605A2016-08-01
10705032009959AVANTI504605P504605P2016-08-01

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