Identity
- Trade Name
- HyperForm FDA UDI
- Generic Name
- Intravascular occluding balloon catheter, image-guided FDA UDI
- Device Name
- BALLOON SYSTEM 104-4370 V20 HYPERFORM FDA UDI
- Model / Reference
- 104-4370 FDA UDI
- Description
- BALLOON SYSTEM 104-4370 V20 HYPERFORM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000294175 FDA UDI
- 510(k) Number
- K101570 FDA UDI
- FDA Product Code
- MJN FDA UDI
- GMDN Term
- Intravascular occluding balloon catheter, image-guided FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4450 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intravascular occluding balloon catheter, image-guided
HyperForm by Micro Therapeutics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intravascular occluding balloon catheter, image-guided.
- Q50 Plus — QXMedical, LLC · Class II
- Polyurethane Dual Lumen Occlusion Catheter — LeMaitre Vascular, Inc. · Class II
- BOBBY/SOFIA Kit — MICROVENTION INC. · Class II
- Pennig Minifixator — Orthofix, Inc. · Class II
- LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CATHETER — LUCAS MEDICAL INC · Class II
- CELLO™, Balloon Guide Catheter — Fuji Systems Corp. · Class II
- TAPAS® Catheter — Thermopeutix, Inc. · Class II
- EndoCATH — ATRICURE, INC. · Class II
Cleared under the same submission
K101570 also covers:
- HyperForm — Micro Therapeutics, Inc.
- HyperForm — Micro Therapeutics, Inc.
- HyperForm — Micro Therapeutics, Inc.
- HyperForm — Micro Therapeutics, Inc.
- HyperForm — Micro Therapeutics, Inc.
- HyperForm — Micro Therapeutics, Inc.
- HyperFormTM — Micro Therapeutics, Inc.
- HyperFormTM — Micro Therapeutics, Inc.
- HyperFormTM — Micro Therapeutics, Inc.
- HyperFormTM — Micro Therapeutics, Inc.
- HyperFormTM — Micro Therapeutics, Inc.
- HyperFormTM — Micro Therapeutics, 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Micro Therapeutics, Inc.
Sources (1)
- FDA UDI 406cadaf-369c-4da3-b552-19bb873d458a 36 fields · synced May 30, 2026