FDA.reportPublic FDA data

Jade PTA Balloon Dilatation Catheter

Primary DI
06934955960246
Brand
Jade PTA Balloon Dilatation Catheter
Company
OrbusNeich Medical (ShenZhen) Co., Ltd.
Model
603002022
Device description
Percutaneous Transluminal Angioplasty (PTA) Catheter
Published
2020-12-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FDAEnteroscope And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDAEnteroscope And AccessoriesGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202231000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202231000JADEOrbusNeich Medical (Shenzhen) Co., Ltd.2020-12-10LIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06934955960246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934955960246069349559602466934955960246

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
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

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