FDA.reportPublic FDA data

Glider PTCA BAlloon Catheter

Primary DI
M8744100A35201
Brand
Glider PTCA BAlloon Catheter
Company
TRIREME MEDICAL, LLC
Model
B
Published
2017-02-13
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
LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121681000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121681000GLIDER PTCA BALLOON CATHETERTrireme Medical, Inc.2012-06-26LOX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M8744100A35201PrimaryHIBCC0

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
623861577
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M8744100A15041Glider PTCA BAlloon CatheterA4100A15042017-02-13
M8744100A15081Glider PTCA BAlloon CatheterA2017-02-13
M8744100A15121Glider PTCA BAlloon CatheterA2017-02-13
M8744100A15201Glider PTCA BAlloon CatheterA2017-02-13
M8744100A20041Glider PTCA BAlloon CatheterA2017-02-13
M8744100A20081Glider PTCA BAlloon CatheterA2017-02-13
M8744100A20121Glider PTCA BAlloon CatheterA2017-02-13
M8744100A20201Glider PTCA BAlloon CatheterA2017-02-13
M8744100A25041Glider PTCA BAlloon CatheterB2017-02-13
M8744100A25081Glider PTCA BAlloon CatheterB2017-02-13
M8744100A25121Glider PTCA BAlloon CatheterB2017-02-13
M8744100A25201Glider PTCA BAlloon CatheterB2017-02-13
M8744100A30041Glider PTCA BAlloon CatheterB2017-02-13
M8744100A30081Glider PTCA BAlloon CatheterB2017-02-13
M8744100A30121Glider PTCA BAlloon CatheterB2017-02-13
M8744100A30201Glider PTCA BAlloon CatheterB2017-02-13
M8744100A35041Glider PTCA BAlloon CatheterB2017-02-13
M8744100A35081Glider PTCA BAlloon CatheterB2017-02-13
M8744100A35121Glider PTCA BAlloon CatheterB2017-02-13
M874CD141402010RX1Chocolate XD PTCA Balloon Catheter NHCACD141402010RX2018-02-05

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