FDA UDI
In Commercial Distribution
🇺🇸 United States
All'InCath 035M PTA Balloon Dilatation Catheter
DI: 03701261100344
·
Model: 1
·
NEXSTEP MEDICAL
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- All'InCath 035M PTA Balloon Dilatation Catheter
- Primary DI
- 03701261100344
- Version / Model
- 1
- Catalog Number
- AL035P-80-7x60
- Company Name
- NEXSTEP MEDICAL
- Labeler DUNS
- 266039102
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-12
- Public Version
- 1
- Public Version Date
- 2025-06-20
- Public Version Status
- New
- Public Device Record Key
- 9230c3d8-bf36-4619-a228-b8baf1af33df
Device Description
All'InCath 035M PTA Balloon Dilatation Catheter
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | 870.1250 | 2 |
| KRA | Catheter, Continuous Flush | Cardiovascular | 870.1210 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17184 | Peripheral angioplasty balloon catheter, basic | A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03701261100344 | GS1 |
Customer Contacts
- Phone
- 9999999999
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191275 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Working Length | 80 | Centimeter | |
| Balloon Diameter | 7 | Millimeter | |
| Balloon Length | 60 | Millimeter | |
| Balloon Rated Burst Pressure | 15 | Atmosphere | |
| Introducer Sheath Compatibility | 6 | French | |
| Guidewire Compatibility | 0.035 | French | |
| Pressure | 1100 | Pound per Square Inch | |
| Balloon Nominal (Inflation) Pressure | 11 | Atmosphere |