Identity
- Trade Name
- Balloon Catheter FDA UDI
- Generic Name
- Inflatable bone tamp FDA UDI
- Device Name
- Balloon Catheter, 15mm FDA UDI
- Model / Reference
- FA1115 FDA UDI
- Description
- Balloon Catheter, 15mm FDA UDI
Identifiers
- Catalog Number
- FA1115 FDA UDI
- Primary DI / UDI-DI
- 06938695537812 FDA UDI
- 510(k) Number
- K113742 FDA UDI
- FDA Product Code
- HRX FDA UDINDN FDA UDI
- GMDN Term
- Inflatable bone tamp FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 FDA UDI888.3027 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Balloon Length — 15 Millimeter FDA UDI
Category: Inflatable bone tamp
Balloon Catheter by Shanghai Kinetic Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Inflatable bone tamp.
- KYPHON Express II Inflatable Bone Tamp — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- SpineKure Kyphoplasty System — Hanchang Co., Ltd. · Class II
- MEDINAUT Plus Kyphoplasty System — IMEDICOM CO., LTD. · Class II
- SYNTH™ PLUS — IMEDICOM CO., LTD. · Class II
- KYPHON Xpander™ Inflatable Bone Tamp — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- KYPHON® Express™ Inflatable Bone Tamp — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- Arcadia™ — Merit Medical Systems, Inc. · Class II
- Arcadia™ — Merit Medical Systems, Inc. · Class II
Cleared under the same submission
K113742 also covers:
- Access Needle — Shanghai Kinetic Medical Co., Ltd.
- Balloon Catheter — Shanghai Kinetic Medical Co., Ltd.
- Balloon Catheter — Shanghai Kinetic Medical Co., Ltd.
- Balloon Catheter Curved — Shanghai Kinetic Medical Co., Ltd.
- Balloon Catheter Syringe Pump — Shanghai Kinetic Medical Co., Ltd.
- Bone Filler Device — Shanghai Kinetic Medical Co., Ltd.
- Bone Filler Device — Shanghai Kinetic Medical Co., Ltd.
- Cannula — Shanghai Kinetic Medical Co., Ltd.
- Drill — Shanghai Kinetic Medical Co., Ltd.
- KMC Access Needle, 11 Gauge, 115mm, Pyramid Tip — Shanghai Kinetic Medical Co., Ltd.
- KMC Access Needle, 11 Gauge, 95mm, Pyramid Tip — Shanghai Kinetic Medical Co., Ltd.
- KMC Access Needle, 13 Gauge, 115mm, Integrated Bevel Tip — Shanghai Kinetic Medical Co., Ltd.
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
- Shanghai Kinetic Medical Co., Ltd.
Sources (1)
- FDA UDI e216ec71-27dd-43af-9248-7909ccf6f0b5 38 fields · synced Jun 8, 2026