| Primary Device ID | 03701261100115 |
| NIH Device Record Key | 905267be-eee1-4d19-afbc-3c18a8f73a5c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | All'InCath 035M PTA Balloon Dilatation Catheter |
| Version Model Number | 1 |
| Catalog Number | AL035P-120-7x40 |
| Company DUNS | 266039102 |
| Company Name | NEXSTEP MEDICAL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Catheter Working Length | 120 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Rated Burst Pressure | 15 Atmosphere |
| Introducer Sheath Compatibilit | 7 French |
| Guidewire Compatibility | 0.035 French |
| Balloon Nominal (Inflation) Pr | 11 Atmosphere |
| Catheter Working Length | 120 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Rated Burst Pressure | 15 Atmosphere |
| Introducer Sheath Compatibilit | 7 French |
| Guidewire Compatibility | 0.035 French |
| Balloon Nominal (Inflation) Pr | 11 Atmosphere |
| Catheter Working Length | 120 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Rated Burst Pressure | 15 Atmosphere |
| Introducer Sheath Compatibilit | 7 French |
| Guidewire Compatibility | 0.035 French |
| Balloon Nominal (Inflation) Pr | 11 Atmosphere |
| Catheter Working Length | 120 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Rated Burst Pressure | 15 Atmosphere |
| Introducer Sheath Compatibilit | 7 French |
| Guidewire Compatibility | 0.035 French |
| Balloon Nominal (Inflation) Pr | 11 Atmosphere |
| Catheter Working Length | 120 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Rated Burst Pressure | 15 Atmosphere |
| Introducer Sheath Compatibilit | 7 French |
| Guidewire Compatibility | 0.035 French |
| Balloon Nominal (Inflation) Pr | 11 Atmosphere |
| Catheter Working Length | 120 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Rated Burst Pressure | 15 Atmosphere |
| Introducer Sheath Compatibilit | 7 French |
| Guidewire Compatibility | 0.035 French |
| Balloon Nominal (Inflation) Pr | 11 Atmosphere |
| Catheter Working Length | 120 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Rated Burst Pressure | 15 Atmosphere |
| Introducer Sheath Compatibilit | 7 French |
| Guidewire Compatibility | 0.035 French |
| Balloon Nominal (Inflation) Pr | 11 Atmosphere |
| Catheter Working Length | 120 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Rated Burst Pressure | 15 Atmosphere |
| Introducer Sheath Compatibilit | 7 French |
| Guidewire Compatibility | 0.035 French |
| Balloon Nominal (Inflation) Pr | 11 Atmosphere |
| Catheter Working Length | 120 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Rated Burst Pressure | 15 Atmosphere |
| Introducer Sheath Compatibilit | 7 French |
| Guidewire Compatibility | 0.035 French |
| Balloon Nominal (Inflation) Pr | 11 Atmosphere |
| Catheter Working Length | 120 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Rated Burst Pressure | 15 Atmosphere |
| Introducer Sheath Compatibilit | 7 French |
| Guidewire Compatibility | 0.035 French |
| Balloon Nominal (Inflation) Pr | 11 Atmosphere |
| Catheter Working Length | 120 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Rated Burst Pressure | 15 Atmosphere |
| Introducer Sheath Compatibilit | 7 French |
| Guidewire Compatibility | 0.035 French |
| Balloon Nominal (Inflation) Pr | 11 Atmosphere |
| Catheter Working Length | 120 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Rated Burst Pressure | 15 Atmosphere |
| Introducer Sheath Compatibilit | 7 French |
| Guidewire Compatibility | 0.035 French |
| Balloon Nominal (Inflation) Pr | 11 Atmosphere |
| Catheter Working Length | 120 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Rated Burst Pressure | 15 Atmosphere |
| Introducer Sheath Compatibilit | 7 French |
| Guidewire Compatibility | 0.035 French |
| Balloon Nominal (Inflation) Pr | 11 Atmosphere |
| Catheter Working Length | 120 Centimeter |
| Balloon Diameter | 7 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Rated Burst Pressure | 15 Atmosphere |
| Introducer Sheath Compatibilit | 7 French |
| Guidewire Compatibility | 0.035 French |
| Balloon Nominal (Inflation) Pr | 11 Atmosphere |