Identity
- Trade Name
- APTUS Heli-FX® FDA UDI
- Generic Name
- Soft-tissue/mesh anchor, non-bioabsorbable FDA UDI
- Device Name
- GUIDE HG-16-62-28 AAA ENDOANCH 62CM MDT FDA UDI
- Model / Reference
- HG-16-62-28 FDA UDI
- Description
- GUIDE HG-16-62-28 AAA ENDOANCH 62CM MDT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169647626 FDA UDI
- 510(k) Number
- K140036 FDA UDI
- FDA Product Code
- OTD FDA UDI
- GMDN Term
- Soft-tissue/mesh anchor, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3460 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 5.3 Millimeter FDA UDI
APTUS Heli-FX® by Medtronic Vascular, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- Medtronic Vascular, Inc.
Sources (1)
- FDA UDI 470e8009-1b85-4cdb-805a-0a484d3c9384 38 fields · synced Jun 1, 2026