Chocolate™

Primary DI
00763000500221
Brand
Chocolate™
Company
MEDTRONIC, INC.
Model
CB1812060080OTW
Device description
PTA CB1812060080 CHOCOLATE 018 V05
Published
2023-03-09
Public version status
New
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
LITCatheter, angioplasty, peripheral, transluminal

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213631000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213631000Chocolate PTA Balloon CatheterMedtronic, Inc.2021-12-15LIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000500221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000500221007630005002217630005002210763000500221

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Balloon Diameter6Millimeter
Balloon Length80Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length120Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
Special Storage Condition, Specify00Store the device in a dry area away from sunlight.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true

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00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30

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