Identity
- Trade Name
- InterV FDA UDI
- Generic Name
- Kyphoplasty balloon catheter FDA UDI
- Device Name
- 8 Gauge 15mm Balloon Kyphoplasty Catheter FDA UDI
- Model / Reference
- INTV-15 FDA UDI
- Description
- 8 Gauge 15mm Balloon Kyphoplasty Catheter FDA UDI
Identifiers
- Catalog Number
- INTV-15 FDA UDI
- Primary DI / UDI-DI
- 15060270906268 FDA UDI
- 510(k) Number
- K132620 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Kyphoplasty balloon catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 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
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Kyphoplasty balloon catheter
InterV by Pan Medical Us Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Kyphoplasty balloon catheter.
- BALEX Bone Expander System — Taeyeon Medical Co., Ltd. · Class I
- BALEX Bone Expander System — Taeyeon Medical Co., Ltd. · Class I
- BIOPSYBELL — BIOPSYBELL SRL · Class II
- Kypho Balloon Catheter 22/16 — Joline GmbH & Co. KG · Class II
- BALEX Bone Expander System — Taeyeon Medical Co., Ltd. · Class I
- Kypho Balloon Catheter 16/16 — Joline GmbH & Co. KG · Class II
- BIOPSYBELL — BIOPSYBELL SRL · Class II
- BIOPSYBELL — BIOPSYBELL SRL · Class II
Cleared under the same submission
K132620 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pan Medical Us Corporation
Sources (1)
- FDA UDI cc688cd5-6f18-403d-99c7-e46476e789e5 36 fields · synced May 31, 2026