FDA.reportPublic FDA data

OPN NC

Primary DI
07640142570615
Brand
OPN NC
Company
SIS Medical AG
Model
350-020-004
Device description
OPN NC Ø3.5x20 PTCA catheters
Published
2022-12-12
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

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
K212393000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212393000OPN NC PTCA Dilatation CatheterSis Medical AG2022-03-14LOX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640142570615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640142570615076401425706157640142570615

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Regulatory Flags#

DUNS number
483665555
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
07640142570509OPN NC200-010-0042022-12-12
07640142570516OPN NC200-015-0042022-12-12
07640142570523OPN NC200-020-0042022-12-12
07640142570530OPN NC250-010-0042022-12-12
07640142570547OPN NC250-015-0042022-12-12
07640142570554OPN NC250-020-0042022-12-12
07640142570561OPN NC300-010-0042022-12-12
07640142570578OPN NC300-015-0042022-12-12
07640142570585OPN NC300-020-0042022-12-12
07640142570592OPN NC350-010-0042022-12-12
07640142570608OPN NC350-015-0042022-12-12
07640142570622OPN NC400-010-0042022-12-12
07640142570639OPN NC400-015-0042022-12-12
07640142570646OPN NC400-020-0042022-12-12
07640142572855OPN NC150-010-0042022-12-12
07640142572862OPN NC150-015-0042022-12-12
07640142572879OPN NC150-020-0042022-12-12
07640142572886OPN NC450-010-0042022-12-12
07640142572893OPN NC450-015-0042022-12-12
07640142572909OPN NC450-020-0042022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
06971591769093Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
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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