Identity
- Trade Name
- CROSSTELLA RX FDA UDI
- Generic Name
- Peripheral angioplasty balloon catheter, basic FDA UDI
- Device Name
- CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm). FDA UDI
- Model / Reference
- BD-F30020ER FDA UDI
- Description
- CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm). FDA UDI
Identifiers
- Catalog Number
- BD-F30020ER FDA UDI
- Primary DI / UDI-DI
- 04540778159532 FDA UDI
- 510(k) Number
- K152873 FDA UDI
- FDA Product Code
- LIT FDA UDI
- GMDN Term
- Peripheral angioplasty balloon catheter, basic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 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: Peripheral angioplasty balloon catheter, basic
Crosstella Rx by Kaneka Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral angioplasty balloon catheter, basic.
- Minerva PTA Balloon Dilatation Catheter — BrosMed Medical Co., Ltd. · Class IIa
- Advocate™ — Merit Medical Systems, Inc. · Class II
- Senri — KANEKA Corporation · Class IIa
- Jade PTA Balloon Dilatation Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd. · Class II
- ZENFluxion — Zylox-Tonbridge Medical Technology Co., Ltd. · Class III
- Pacific™ Plus — MEDTRONIC, INC. · Class II
- Metacross OTW — KANEKA Corporation · Class IIa
- Armada — Abbott Vascular · Class II
Cleared under the same submission
K152873 also covers:
- CROSSTELLA RX — Kaneka Corp.
- CROSSTELLA RX — Kaneka Corp.
- CROSSTELLA RX — Kaneka Corp.
- CROSSTELLA RX — Kaneka Corp.
- CROSSTELLA RX — Kaneka Corp.
- CROSSTELLA RX — Kaneka Corp.
- CROSSTELLA RX — Kaneka Corp.
- CROSSTELLA RX — Kaneka Corp.
- CROSSTELLA RX — Kaneka Corp.
- CROSSTELLA RX — Kaneka Corp.
- CROSSTELLA RX — Kaneka Corp.
- CROSSTELLA RX — 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 80b3f433-60e0-429b-a09f-3b81af8e4656 38 fields · synced May 31, 2026