FDA UDI
In Commercial Distribution
🇺🇸 United States
RX TAKERU
DI: 04540778168275
·
Model: DC-RY3520UA2
·
KANEKA CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RX TAKERU
- Primary DI
- 04540778168275
- Version / Model
- DC-RY3520UA2
- Catalog Number
- DC-RY3520UA2
- Company Name
- KANEKA CORPORATION
- Labeler DUNS
- 690535406
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-01
- Public Version
- 4
- Public Version Date
- 2019-10-07
- Public Version Status
- Update
- Public Device Record Key
- 2e581ba3-417d-4ec8-a9a7-339052230b78
Device Description
RX TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter for coronary indications. RX TAKERU is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
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
- Yes
- 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 |
|---|---|---|---|---|
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | Cardiovascular | 870.5100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47732 | Coronary angioplasty balloon catheter, basic | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04540778168275 | GS1 |
Customer Contacts
- Phone
- 800-888-3786
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163372 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Maximum Guidewire Diameter; 0.014 inch | ||
| Device Size Text, specify | Compatible Guiding Catheter; 5 Fr | ||
| Device Size Text, specify | Rated Burst Pressure; 14 atm | ||
| Device Size Text, specify | Nominal Pressure; 6 atm | ||
| Device Size Text, specify | Proximal Shaft Diameter; 2.0 Fr | ||
| Device Size Text, specify | Distal Shaft Diameter; 2.5 Fr | ||
| Device Size Text, specify | Catheter Working Length; 1450 mm | ||
| Device Size Text, specify | Balloon Length; 20 mm | ||
| Device Size Text, specify | Balloon Diameter; 3.5 mm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry, dark place. Avoid exposure to water, direct sunlight.