Identity
- Trade Name
- Agilis™ FDA UDI
- Generic Name
- Cardiac transseptal needle, single-use FDA UDI
- Device Name
- TRANSSEPTAL KIT FDA UDI
- Model / Reference
- 408312 FDA UDI
- Description
- TRANSSEPTAL KIT FDA UDI
Identifiers
- Catalog Number
- 408312 FDA UDI
- Primary DI / UDI-DI
- 05414734206167 FDA UDI
- 510(k) Number
- K061363 FDA UDI
- FDA Product Code
- DYB FDA UDI
- GMDN Term
- Cardiac transseptal needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1340 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
Yes
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
Dimensions & Sizes
- Size
- Catheter Gauge — 8.5 French FDA UDI
Category: Cardiac transseptal needle, single-use
Agilis™ by St. Jude Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac transseptal needle, single-use.
- Transseptal Needle — PPMDM · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Needle Free Transseptal Cannula — PPMDM · Class II
- HeartSpan® — Merit Medical · Class II
- Needle Free Transseptal Cannula — PPMDM · Class II
- SafeSharp Transseptal Needle — PPMDM · Class II
- SafeSept Blunt Needle — PPMDM · Class II
- HeartSpan® — Merit Medical · Class II
Cleared under the same submission
K061363 also covers:
- Agilis™ — ST. JUDE MEDICAL, INC.
- Agilis™ — ST. JUDE MEDICAL, INC.
- Agilis™ — ST. JUDE MEDICAL, INC.
- Agilis™ — ST. JUDE MEDICAL, INC.
- Agilis™ — ST. JUDE MEDICAL, INC.
- Agilis™ — ST. JUDE MEDICAL, INC.
- Agilis™ — ST. JUDE MEDICAL, INC.
- Agilis™ — ST. JUDE MEDICAL, INC.
- Agilis™ — ST. JUDE MEDICAL, INC.
- Agilis™ — ST. JUDE MEDICAL, 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 |
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Manufacturer
- Manufacturer
- St. Jude Medical, Inc.
Sources (1)
- FDA UDI 2305ce69-a1d1-42ad-8bc4-fa64bf4f5a4e 38 fields · synced Jun 8, 2026