Identity
- Trade Name
- Mini Ghost™ FDA UDI
- Generic Name
- Peripheral angioplasty balloon catheter, basic FDA UDI
- Device Name
- MG152 MINI GHOST BALLOON 6 X 4 X 40 FDA UDI
- Model / Reference
- 612526 FDA UDI
- Description
- MG152 MINI GHOST BALLOON 6 X 4 X 40 FDA UDI
Identifiers
- Catalog Number
- 612526 FDA UDI
- Primary DI / UDI-DI
- 04046964340925 FDA UDI
- 510(k) Number
- K051343 FDA UDI
- FDA Product Code
- DQY 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Peripheral angioplasty balloon catheter, basic
The Mini Ghost is a non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate stenotic peripheral arteries. It's an over-the-wire balloon catheter with multiple lumens or rapid exchange types, suitable for implantable procedures likePeripheral angioplasty. The device is sterile, non-drug eluting, and made of flexible material. Made by Braun Interventional Systems, the Mini Ghost is approved for use in patients with certain medical conditions.
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
K051343 also covers:
- Mini Ghost™ — B BRAUN INTERVENTIONAL SYSTEMS, INC
- Mini Ghost™ — B BRAUN INTERVENTIONAL SYSTEMS, INC
- Mini Ghost™ — B BRAUN INTERVENTIONAL SYSTEMS, INC
- Mini Ghost™ — B BRAUN INTERVENTIONAL SYSTEMS, INC
- Mini Ghost™ — B BRAUN INTERVENTIONAL SYSTEMS, INC
- Mini Ghost™ — B BRAUN INTERVENTIONAL SYSTEMS, INC
- Mini Ghost™ — B BRAUN INTERVENTIONAL SYSTEMS, INC
- Mini Ghost™ — B BRAUN INTERVENTIONAL SYSTEMS, INC
- Mini Ghost™ — B BRAUN INTERVENTIONAL SYSTEMS, INC
- Mini Ghost™ — B BRAUN INTERVENTIONAL SYSTEMS, INC
- Mini Ghost™ — B BRAUN INTERVENTIONAL SYSTEMS, INC
- Mini Ghost™ — B BRAUN INTERVENTIONAL SYSTEMS, INC
Authorization Coverage (1 country)
Regulatory Authorizations
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
- B Braun Interventional Systems, Inc
Sources (1)
- FDA UDI c1953975-7f3e-4e23-bf31-954907f24929 37 fields · synced Jul 18, 2026