FDA UDI
In Commercial Distribution
🇺🇸 United States
OTW TAKERU
DI: 04540778169616
·
Model: DC-PY3720UA2
·
KANEKA CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OTW TAKERU
- Primary DI
- 04540778169616
- Version / Model
- DC-PY3720UA2
- Catalog Number
- DC-PY3720UA2
- Company Name
- KANEKA CORPORATION
- Labeler DUNS
- 690535406
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-26
- Public Version
- 3
- Public Version Date
- 2019-10-07
- Public Version Status
- Update
- Public Device Record Key
- 321bce35-5bdf-4731-9b5c-2aea5d9d0eb8
Device Description
OTW TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter for coronary indications. OTW TAKERU is an over the wire (OTW) 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 | 04540778169616 | GS1 |
Customer Contacts
- Phone
- 800-888-3786
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172264 | 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; 3.8 Fr | ||
| Device Size Text, specify | Distal Shaft Diameter; 2.8 Fr | ||
| Device Size Text, specify | Catheter Working Length; 1450 mm | ||
| Device Size Text, specify | Balloon Length; 20 mm | ||
| Device Size Text, specify | Balloon Diameter; 3.75 mm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry, dark place. Avoid exposure to water, direct sunlight.