FDA UDI
In Commercial Distribution
🇺🇸 United States
CROSSTELLA OTW
DI: 04540778161375
·
Model: BD-F50200MW
·
KANEKA CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CROSSTELLA OTW
- Primary DI
- 04540778161375
- Version / Model
- BD-F50200MW
- Catalog Number
- BD-F50200MW
- Company Name
- KANEKA CORPORATION
- Labeler DUNS
- 690535406
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-26
- Public Version
- 4
- Public Version Date
- 2019-08-09
- Public Version Status
- Update
- Public Device Record Key
- 4fe5ad41-608e-47c1-819a-fa54a1a51c30
Device Description
CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46 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 |
|---|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | 870.1250 | 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 | 04540778161375 | GS1 |
Customer Contacts
- Phone
- 800-888-3786
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160004 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Maximum Guidewire Diameter; 0.018 inch | ||
| Device Size Text, specify | Compatible Sheath Diameter; 5 Fr | ||
| Device Size Text, specify | Rated Burst Pressure; 14 atm | ||
| Device Size Text, specify | Nominal Pressure; 8 atm | ||
| Device Size Text, specify | Shaft Diameter; 4.3 Fr | ||
| Device Size Text, specify | Catheter Working Length; 900 mm | ||
| Device Size Text, specify | Balloon Length; 200 mm | ||
| Device Size Text, specify | Balloon Diameter; 5.0 mm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry, dark place. Avoid exposure to water, direct sunlight.