Advocate
- Primary DI
- 05397132007782
- Brand
- Advocate
- Company
- ARRAVASC LIMITED
- Model
- A35030150130
- Device description
- Advocate 0.035” PTA Catheter (3.0mm x 150mm x 1300mm)
- Published
- 2016-09-13
- 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
Contact Domains#
arravasc.comProduct Codes#
| Code | Name |
|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K161427 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 05397132007782 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 05397132007782 | 05397132007782 | 5397132007782 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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 microsurgical blades (atherotomes) to score the plaque. This is a single-use device. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Length | 150 | Millimeter |
| Outer Diameter | 3 | Millimeter |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | Store in a dark, dry, cool place. Avoid extended exposure to light, organic solvents, ionizing radiation or ultraviolet light |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +353091758939 | cs@arravasc.com |
Regulatory Flags#
- DUNS number
- 896165250
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- 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
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 05397132005528 | Advocate | A18040040045 | 2016-08-02 | |
| 05397132005535 | Advocate | A18040060045 | 2016-09-07 | |
| 05397132005542 | Advocate | A18050040045 | 2016-09-01 | |
| 05397132005559 | Advocate | A18050060045 | 2016-09-01 | |
| 05397132005566 | Advocate | A18060040045 | 2016-09-01 | |
| 05397132005573 | Advocate | A18060060045 | 2016-09-01 | |
| 05397132005580 | Advocate | A18070040045 | 2016-09-01 | |
| 05397132005597 | Advocate | A18070060045 | 2016-09-01 | |
| 05397132005603 | Advocate | A18020060090 | 2016-09-01 | |
| 05397132005610 | Advocate | A18020080090 | 2016-09-01 | |
| 05397132005627 | Advocate | A18020100090 | 2016-09-01 | |
| 05397132005634 | Advocate | A18025060090 | 2016-09-01 | |
| 05397132005641 | Advocate | A18025080090 | 2016-09-01 | |
| 05397132005658 | Advocate | A18025100090 | 2016-09-01 | |
| 05397132005665 | Advocate | A18030040090 | 2016-09-01 | |
| 05397132005672 | Advocate | A18030060090 | 2016-09-01 | |
| 05397132005689 | Advocate | A18030080090 | 2016-09-01 | |
| 05397132005696 | Advocate | A18030100090 | 2016-09-01 | |
| 05397132005702 | Advocate | A18030150090 | 2016-09-01 | |
| 05397132005719 | Advocate | A18030200090 | 2016-09-01 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 07640119558639 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558646 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558653 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558660 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558677 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558684 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558691 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558707 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558714 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558721 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558738 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558745 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558752 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558769 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558776 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558783 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558790 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558806 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558813 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558820 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558837 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558844 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558851 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558868 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558875 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558882 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558899 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558905 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558912 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558929 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |