Identity
- Trade Name
- Gliderflex PTA Balloon Catheter FDA UDI
- Generic Name
- Peripheral angioplasty balloon catheter, basic FDA UDI
- Model / Reference
- B FDA UDI
Identifiers
- Primary DI / UDI-DI
- M8746000CB400601 FDA UDI
- 510(k) Number
- K101062 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
No
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
Category: Peripheral angioplasty balloon catheter, basic
Gliderflex PTA Balloon Catheter by Trireme Medical, Llc — 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
K101062 also covers:
- Gliderflex PTA Balloon Catheter — TRIREME MEDICAL, LLC
- Gliderflex PTA Balloon Catheter — TRIREME MEDICAL, LLC
- Gliderflex PTA Balloon Catheter — TRIREME MEDICAL, LLC
- Gliderflex PTA Balloon Catheter — TRIREME MEDICAL, LLC
- Gliderflex PTA Balloon Catheter — TRIREME MEDICAL, LLC
- Gliderflex PTA Balloon Catheter — TRIREME MEDICAL, LLC
- Gliderflex PTA Balloon Catheter — TRIREME MEDICAL, LLC
- Gliderflex PTA Balloon Catheter — TRIREME MEDICAL, LLC
- Gliderflex PTA Balloon Catheter — TRIREME MEDICAL, LLC
- Gliderflex PTA Balloon Catheter — TRIREME MEDICAL, LLC
- Gliderflex PTA Balloon Catheter — TRIREME MEDICAL, LLC
- Gliderflex PTA Balloon Catheter — TRIREME MEDICAL, LLC
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
- Trireme Medical, Llc
Sources (1)
- FDA UDI 7d2985c7-d1e7-47e3-a336-3cee0350aee5 33 fields · synced Jun 8, 2026