FDA.reportPublic FDA data

Pantera LEO

Primary DI
07640130415829
Brand
Pantera LEO
Company
Biotronik AG
Model
2.0/20/145
Catalog number
367024
Published
2017-02-03
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
LOXCatheters, transluminal coronary angioplasty, percutaneous

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163660000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163660000Pantera LEOBiotronik, Inc.2017-01-26LOX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640130415829PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640130415829076401304158297640130415829

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Handling Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit
Special Storage Condition, Specify00Keep away from sunlight Keep dry
Special Storage Condition, Specify00Keep dry Keep away from sunlight
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)345-0374jon.brumbaugh@biotronik.com
612-423-1738FDA.US.Agent@teleflex.com

Regulatory Flags#

DUNS number
480862817
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640130451490Passeo-35 Xeo4/20/904287782023-02-28
07640130451506Passeo-35 Xeo5/20/904287792023-02-28
07640130451513Passeo-35 Xeo6/20/904287802023-02-28
07640130451520Passeo-35 Xeo7/20/904287812023-02-28
07640130451537Passeo-35 Xeo8/20/904287822023-02-28
07640130451544Passeo-35 Xeo9/20/904287832023-02-28
07640130451551Passeo-35 Xeo10/20/904287842023-02-28
07640130451575Passeo-35 Xeo3/40/904287862023-02-28
07640130451582Passeo-35 Xeo4/40/904287872023-02-28
07640130451599Passeo-35 Xeo5/40/904287882023-02-28
07640130451605Passeo-35 Xeo6/40/904287892023-02-28
07640130451612Passeo-35 Xeo7/40/904287902023-02-28
07640130451629Passeo-35 Xeo8/40/904287912023-02-28
07640130451636Passeo-35 Xeo9/40/904287922023-02-28
07640130451643Passeo-35 Xeo10/40/904287932023-02-28
07640130451650Passeo-35 Xeo12/40/904287942023-02-28
07640130451667Passeo-35 Xeo3/60/904287952023-02-28
07640130451674Passeo-35 Xeo4/60/904287962023-02-28
07640130451681Passeo-35 Xeo5/60/904287972023-02-28
07640130451698Passeo-35 Xeo6/60/904287982023-02-28

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
06971591769079Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
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
00763000877033SPRINTER® LEGENDMEDTRONIC, INC.LOX2025-09-19
00763000877040SPRINTER® LEGENDMEDTRONIC, INC.LOX2025-09-19
00763000877057SPRINTER® LEGENDMEDTRONIC, INC.LOX2025-09-19
00763000877064SPRINTER® LEGENDMEDTRONIC, INC.LOX2025-09-19
00763000877071SPRINTER® LEGENDMEDTRONIC, INC.LOX2025-09-19
00763000877088SPRINTER® LEGENDMEDTRONIC, INC.LOX2025-09-19
00763000877095SPRINTER® LEGENDMEDTRONIC, INC.LOX2025-09-19
00763000877101SPRINTER® LEGENDMEDTRONIC, INC.LOX2025-09-19
00763000877118SPRINTER® LEGENDMEDTRONIC, INC.LOX2025-09-19
00763000877125SPRINTER® LEGENDMEDTRONIC, INC.LOX2025-09-19
00763000877132SPRINTER® LEGENDMEDTRONIC, INC.LOX2025-09-19
00763000877149SPRINTER® LEGENDMEDTRONIC, INC.LOX2025-09-19
00763000877156SPRINTER® LEGENDMEDTRONIC, INC.LOX2025-09-19
00763000877163SPRINTER® LEGENDMEDTRONIC, INC.LOX2025-09-19
00763000877170SPRINTER® LEGENDMEDTRONIC, INC.LOX2025-09-19
00763000877187SPRINTER® LEGENDMEDTRONIC, INC.LOX2025-09-19