FDA.reportPublic FDA data

Scoreflex PTA Scoring Balloon Catheter

Primary DI
06934955941313
Brand
Scoreflex PTA Scoring Balloon Catheter
Company
OrbusNeich Medical (ShenZhen) Co., Ltd.
Model
BL630-154CU
Device description
Catheter, Percutaneous, Cutting/Scoring
Published
2019-10-01
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
LITCatheter, Angioplasty, Peripheral, Transluminal
PNOCatheter, Percutaneous, Cutting/Scoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LITCatheter, Angioplasty, Peripheral, TransluminalCardiovascular2
PNOCatheter, Percutaneous, Cutting/ScoringCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182713000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182713000Scoreflex PTA Scoring Balloon CatheterOrbusneich Medical Trading, Inc.2019-06-11PNO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06934955941313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934955941313069349559413136934955941313

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 Diameter3Millimeter
Balloon Length15Millimeter
Catheter Length150Centimeter
Guidewire Diameter0.018Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, cool, dry place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
954-730-0711jpazienza@orbusneich.com

Regulatory Flags#

DUNS number
530923226
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06934955914713Teleport Glide Microcatheter9218-090-012026-07-20
06934955914720Teleport Glide Microcatheter9218-135-012026-07-20
06934955914737Teleport Glide Microcatheter9218-150-012026-07-20
06934955914744Teleport Glide Microcatheter9218-180-012026-07-20
06934955914751Teleport Glide Microcatheter9218-200-012026-07-20
06934955914768Teleport Glide Microcatheter9235-065-012026-07-20
06934955914775Teleport Glide Microcatheter9235-090-012026-07-20
06934955914782Teleport Glide Microcatheter9235-135-012026-07-20
06934955914799Teleport Glide Microcatheter9235-150-012026-07-20
06934955914805Teleport Glide Microcatheter9235-180-012026-07-20
06934955914812Teleport Glide Microcatheter9235-200-012026-07-20
06934955914829Teleport Glide Microcatheter9218-090-112026-07-20
06934955914836Teleport Glide Microcatheter9218-135-112026-07-20
06934955914843Teleport Glide Microcatheter9218-150-112026-07-20
06934955914850Teleport Glide Microcatheter9218-180-112026-07-20
06934955914867Teleport Glide Microcatheter9218-200-112026-07-20
06934955914874Teleport Glide Microcatheter9235-065-112026-07-20
06934955914881Teleport Glide Microcatheter9235-090-112026-07-20
06934955914898Teleport Glide Microcatheter9235-135-112026-07-20
06934955914904Teleport Glide Microcatheter9235-150-112026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06923533801064Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-06-24
06923533801071Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-06-24
06923533801088Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-06-24
06923533801095Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-06-24
06923533801101Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-06-24
06923533801118Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-06-24
06923533801125Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-06-24
06923533801132Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-06-24
06923533801149Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-06-24
06923533801156Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-06-24
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