FDA.reportPublic FDA data

Sapphire II Pro

Primary DI
06934955942143
Brand
Sapphire II Pro
Company
OrbusNeich Medical (ShenZhen) Co., Ltd.
Model
217-153-5UU
Device description
Balloon Dilatation Catheter
Published
2023-05-17
Public version status
Update
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
LITCatheter, Angioplasty, Peripheral, Transluminal
LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LITCatheter, Angioplasty, Peripheral, TransluminalCardiovascular2
LOXCatheters, Transluminal Coronary Angioplasty, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180921000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180921000Sapphire II PRO Balloon Dilatation CatheterOrbusneich Medical Trading, Inc.2018-06-28LOX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06934955942143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934955942143069349559421436934955942143

GMDN Terms#

Term, Definition table
TermDefinition
Coronary angioplasty balloon catheter, basicA flexible tube designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon(s) at its distal tip. It is typically available as: 1) an over-the-wire (OTW) type that has a double or triple-lumen, one for the guidewire and one or two for single- or double-balloon inflation; and 2) a rapid exchange (RX) type with a single-lumen. It is available in various sizes for the dilatation of small, narrowed, or obstructed coronary arteries or bypass grafts. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. 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
06934955934742COREPASS Modular Microcatheter8425-150-022025-03-20
06934955934728COREPASS Modular Microcatheter8422-150-022025-03-01
06934955934735COREPASS Modular Microcatheter8425-135-022025-03-01
06934955934711COREPASS Modular Microcatheter8422-135-022025-03-01
06934955916960Teleport XT Microcatheter7321-090-017321-090-012024-01-25
06934955916977Teleport XT Microcatheter7321-135-017321-135-012024-01-25
06934955916984Teleport XT Microcatheter7321-150-017321-150-012024-01-25
06934955915963Teleport XT Microcatheter7321-090-012025-03-01
06934955915970Teleport XT Microcatheter7321-135-012025-03-01
06934955915987Teleport XT Microcatheter7321-150-012025-03-01
06934955979019Sapphire ULTRA Coronary Dilatation Catheter7910-005-112025-02-20
06934955979026Sapphire ULTRA Coronary Dilatation Catheter7910-008-112025-02-20
06934955979033Sapphire ULTRA Coronary Dilatation Catheter7910-010-112025-02-20
06934955979040Sapphire ULTRA Coronary Dilatation Catheter7910-015-112025-02-20
06934955979057Sapphire ULTRA Coronary Dilatation Catheter7912-005-112025-02-20
06934955979064Sapphire ULTRA Coronary Dilatation Catheter7912-008-112025-02-20
06934955979071Sapphire ULTRA Coronary Dilatation Catheter7912-010-112025-02-20
06934955979088Sapphire ULTRA Coronary Dilatation Catheter7912-015-112025-02-20
06934955979095Sapphire ULTRA Coronary Dilatation Catheter7915-010-112025-02-20
06934955979101Sapphire ULTRA Coronary Dilatation Catheter7915-012-112025-02-20

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