FDA.reportPublic FDA data

Angioway

Primary DI
16936733736132
Brand
Angioway
Company
Lepu Medical Technology (Beijing) Co.,Ltd.
Model
LP-P-30S-YNP25H
Device description
Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment (such as percutaneous coronary angioplasty, PTCA; stent Implantation operation) provides the pressure inside the balloon.
Published
2018-05-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PTMSyringe, Balloon Inflation, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTMSyringe, Balloon Inflation, ExemptCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16936733736132PackageGS15In Commercial Distribution
06936733736135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693673373613216936733736132
06936733736135069367337361356936733736135

GMDN Terms#

Term, Definition table
TermDefinition
Catheter/overtube balloon inflator, single-useA device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529853921
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936733738191BrilliantACS0524212026-04-16
06936733738207BrilliantACS0607212026-04-16
06936733738214BrilliantACS0624212026-04-16
06936733738221BrilliantACS0607352026-04-16
06936733738238BrilliantACS0611352026-04-16
06936733738245BrilliantACS0616352026-04-16
06936733738252BrilliantACS0624352026-04-16
06936733738276BrilliantACS0711352026-04-16
06936733738283BrilliantACS0716352026-04-16
06936733738290BrilliantACS0724352026-04-16
06936733738306BrilliantRSC0407212026-04-16
06936733738313BrilliantRSC040721A2026-04-16
06936733738320BrilliantRSC0407252026-04-16
06936733738337BrilliantRSC0411212026-04-16
06936733738344BrilliantRSC041121A2026-04-16
06936733738351BrilliantRSC0411252026-04-16
06936733738368BrilliantRSC0416212026-04-16
06936733738375BrilliantRSC041621A2026-04-16
06936733738382BrilliantRSC0416252026-04-16
06936733738399BrilliantRSC0424212026-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06941466829177Balloon Inflation DeviceBrosMed Medical Co.,Ltd.PTM2026-05-13
00884450544648basixCOMPAK™Merit Medical Systems, Inc.PTM2026-04-29
00884450638514basixCOMPAK™Merit Medical Systems, Inc.PTM2026-04-29
10197344203475NAMICMEDLINE INDUSTRIES, INC.PTM2026-03-16
30197344203479NAMICMEDLINE INDUSTRIES, INC.PTM2026-03-16
00884450440612basixTOUCH™Merit Medical Systems, Inc.PTM2026-02-20
20884450440616basixTOUCH™Merit Medical Systems, Inc.PTM2026-02-20
10889942546350NamicMEDLINE INDUSTRIES, INC.PTM2025-12-18
40889942546351NamicMEDLINE INDUSTRIES, INC.PTM2025-12-18
06936841212620Balloon Inflation DeviceTianck Medical Co., Ltd.PTM2025-11-12
06936841236329Balloon Inflation DeviceTianck Medical Co., Ltd.PTM2025-11-12
00884450098684basixTOUCH™Merit Medical Systems, Inc.PTM2025-11-04
00884450220092basixTOUCH™Merit Medical Systems, Inc.PTM2025-11-04
00884450098288basixTOUCH™Merit Medical Systems, Inc.PTM2025-10-07
00724995244538LumiflexUS EndoscopyPTM2025-08-19
10724995244535LumiflexUS EndoscopyPTM2025-08-19
00884450860373BIG60™Merit Medical Systems, Inc.PTM2025-05-31
10884450860370BIG60™Merit Medical Systems, Inc.PTM2025-05-31
20859500005169StopLockFEMASYS INC.PTM2025-05-02
10859500005162StopLockFEMASYS INC.PTM2025-05-02
00859500005165StopLockFEMASYS INC.PTM2025-05-02
30859500005166StopLockFEMASYS INC.PTM2025-05-02
00884450860113basixCOMPAK™Merit Medical Systems, Inc.PTM2025-04-23
10884450860110basixCOMPAK™Merit Medical Systems, Inc.PTM2025-04-23
00884450860106basixCOMPAK™Merit Medical Systems, Inc.PTM2025-04-21
10884450860103basixCOMPAK™Merit Medical Systems, Inc.PTM2025-04-21
00884450860953basixCOMPAK™Merit Medical Systems, Inc.PTM2025-04-15
10884450860950basixCOMPAK™Merit Medical Systems, Inc.PTM2025-04-15
00884450621370basixTOUCH™Merit Medical Systems, Inc.PTM2025-01-15
00884450621394basixTOUCH™Merit Medical Systems, Inc.PTM2025-01-15