Identity
- Trade Name
- OTW TAKERU FDA UDI
- Generic Name
- Coronary angioplasty balloon catheter, basic FDA UDI
- Device Name
- 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). FDA UDI
- Model / Reference
- DC-PY2010UA2 FDA UDI
- 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). FDA UDI
Identifiers
- Catalog Number
- DC-PY2010UA2 FDA UDI
- Primary DI / UDI-DI
- 04540778168879 FDA UDI
- 510(k) Number
- K172264 FDA UDI
- FDA Product Code
- LOX FDA UDI
- GMDN Term
- Coronary angioplasty balloon catheter, basic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Coronary angioplasty balloon catheter, basic
Otw Takeru by Kaneka Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Coronary angioplasty balloon catheter, basic.
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- Pantera Pro — Biotronik, Inc. · Class II
- SPRINTER LEGEND — MEDTRONIC, INC. · Class II
- SPRINTER® LEGEND — MEDTRONIC, INC. · Class II
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Cleared under the same submission
K172264 also covers:
- OTW TAKERU — Kaneka Corp.
- OTW TAKERU — Kaneka Corp.
- OTW TAKERU — Kaneka Corp.
- OTW TAKERU — Kaneka Corp.
- OTW TAKERU — Kaneka Corp.
- OTW TAKERU — Kaneka Corp.
- OTW TAKERU — Kaneka Corp.
- OTW TAKERU — Kaneka Corp.
- OTW TAKERU — Kaneka Corp.
- OTW TAKERU — Kaneka Corp.
- OTW TAKERU — Kaneka Corp.
- OTW TAKERU — Kaneka Corp.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Kaneka Corp.
Sources (1)
- FDA UDI db4a6af1-30f7-4934-a1ce-d313627e4e68 38 fields · synced May 30, 2026