FDA.reportPublic FDA data

Sapphire NC 24 Coronary Dilatation Catheter

Primary DI
06934955905711
Brand
Sapphire NC 24 Coronary Dilatation Catheter
Company
OrbusNeich Medical (ShenZhen) Co., Ltd.
Model
493502612
Published
2022-02-17
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
LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOXCatheters, Transluminal Coronary Angioplasty, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211807000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211807000Sapphire NC 24OrbusNeich Medical (Shenzhen) Co., Ltd.2021-10-14LOX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06934955905711PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934955905711069349559057116934955905711

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
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
00810219610071FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
00810219610088FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
00810219610095FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
00810219610101FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
00810219610118FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
06971591769062Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
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06971591769086Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
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06971591769109Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769116Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769123Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769130Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769147Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
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