Identity
- Trade Name
- IN.PACT™ AV FDA UDI
- Generic Name
- Peripheral angioplasty balloon catheter, drug-coated FDA UDI
- Device Name
- DCB IAV07008008P 07.00 L080 UL0800 US FDA UDI
- Model / Reference
- IAV07008008P FDA UDI
- Description
- DCB IAV07008008P 07.00 L080 UL0800 US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000232634 FDA UDI
- PMA Number
- P190008 FDA UDI
- FDA Product Code
- PRC 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
Yes
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Dimensions & Sizes
- Size
- Outer Diameter — 7.0 Millimeter FDA UDILength — 80.0 Millimeter FDA UDI
Category: Peripheral angioplasty balloon catheter, drug-coated
Discover the IN.PACT AV drug-coated peripheral transluminal angioplasty catheter, a cutting-edge device designed for controlled dilation of stenotic peripheral arteries, while preventing restenosis. With its unique drug-release mechanism and rapid exchange design, this single-use device offers improved patient outcomes.
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
P190008 also covers:
- IN.PACT™ AV — MEDTRONIC, INC.
- IN.PACT™ AV — MEDTRONIC, INC.
- IN.PACT™ AV — MEDTRONIC, INC.
- IN.PACT™ AV — MEDTRONIC, INC.
- IN.PACT™ AV — MEDTRONIC, INC.
- IN.PACT™ AV — MEDTRONIC, INC.
- IN.PACT™ AV — MEDTRONIC, INC.
- IN.PACT™ AV — MEDTRONIC, INC.
- IN.PACT™ AV — MEDTRONIC, INC.
- IN.PACT™ AV — MEDTRONIC, INC.
- IN.PACT™ AV — MEDTRONIC, INC.
- IN.PACT™ AV — MEDTRONIC, 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 III | Pending data |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI 9c207510-54c9-4da7-aeee-3b128f31ccf4 37 fields · synced Jul 25, 2026