Identity
- Trade Name
- In.Pact™ 018 FDA UDI
- Generic Name
- Peripheral angioplasty balloon catheter, drug-coated FDA UDI
- Device Name
- DCB 018 IPU05008020P D5.0 L080 UL0200 FDA UDI
- Model / Reference
- IPU05008020P FDA UDI
- Description
- DCB 018 IPU05008020P D5.0 L080 UL0200 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000291402 FDA UDI
- PMA Number
- P140010 FDA UDI
- FDA Product Code
- ONU FDA UDI
- GMDN Term
- Peripheral angioplasty balloon catheter, drug-coated FDA UDI
Classification
- Device Class
- Class III 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
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 80.0 Millimeter FDA UDIOuter Diameter — 5.0 Millimeter FDA UDI
Category: Peripheral angioplasty balloon catheter, drug-coated
In.Pact™ 018 by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral angioplasty balloon catheter, drug-coated.
- Stellarex 0.035" OTW drug-coated angioplasty balloon — Philips Image Guided Therapy Corporation · Class III
- Ranger™ — Boston Scientific · Class III
- Lutonix® Drug Coated Balloon — Lutonix · Class III
- LUTONIX ® 035 Drug Coated Balloon PTA Catheter — Lutonix · Class III
- Stellarex — Philips Image Guided Therapy Corporation · Class III
- Stellarex 0.035" OTW drug-coated angioplasty balloon — Philips Image Guided Therapy Corporation · Class III
- LUTONIX® Drug Coated Balloon — Lutonix · Class III
- LUTONIX® Drug Coated Balloon — Lutonix · Class III
Cleared under the same submission
P140010 also covers:
- IN.PACT™ Admiral™ — MEDTRONIC, INC.
- IN.PACT™ Admiral™ — MEDTRONIC, INC.
- IN.PACT™ Admiral™ — MEDTRONIC, INC.
- IN.PACT™ Admiral™ — MEDTRONIC, INC.
- IN.PACT™ Admiral™ — MEDTRONIC, INC.
- IN.PACT™ Admiral™ — MEDTRONIC, INC.
- IN.PACT™ Admiral™ — MEDTRONIC, INC.
- IN.PACT™ Admiral™ — MEDTRONIC, INC.
- IN.PACT™ Admiral™ — MEDTRONIC, INC.
- IN.PACT™ Admiral™ — MEDTRONIC, INC.
- IN.PACT™ Admiral™ — MEDTRONIC, INC.
- IN.PACT™ Admiral™ — MEDTRONIC, INC.
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 III | Pending data |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI 849c1237-d956-4476-b396-9ee7d0a80a96 37 fields · synced May 31, 2026