Identity
- Trade Name
- AGILITY FDA UDI
- Generic Name
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
- Device Name
- AGILITY 16 STEERABLE GUIDEWIRES Guidewire Dia. .016 Inch (.40mm) Usable Length 175cm 10cm Steerable Guidewire with Hydrophilic Coating Tip Flexibility Soft Contents: 1 guidewire, 1 torquing device and 1 introducer. FDA UDI
- Model / Reference
- 614-542 FDA UDI
- Description
- AGILITY 16 STEERABLE GUIDEWIRES Guidewire Dia. .016 Inch (.40mm) Usable Length 175cm 10cm Steerable Guidewire with Hydrophilic Coating Tip Flexibility Soft Contents: 1 guidewire, 1 torquing device and 1 introducer. FDA UDI
Identifiers
- Catalog Number
- 614542 FDA UDI
- Primary DI / UDI-DI
- 10886704029090 FDA UDI
- 510(k) Number
- K133625 FDA UDI
- FDA Product Code
- DQX FDA UDIMOF FDA UDI
- GMDN Term
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1330 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
Category: Cardiac/peripheral vascular guidewire, single-use
Agility by Cerenovus, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K133625 also covers:
- AGILITY — Cerenovus, Inc.
- AGILITY — Cerenovus, Inc.
- AGILITY — Cerenovus, Inc.
- AGILITY — Cerenovus, Inc.
- AGILITY — Cerenovus, Inc.
- AGILITY — Cerenovus, Inc.
- AGILITY — Cerenovus, Inc.
- NEUROSCOUT — Medos International Sàrl
- NEUROSCOUT — Medos International Sàrl
- NEUROSCOUT — Medos International Sàrl
- NEUROSCOUT — Medos International Sàrl
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
- Cerenovus, Inc.
Sources (1)
- FDA UDI da6b23e8-d2ea-4cc6-a394-df3926cda3ae 36 fields · synced May 29, 2026