Identity
- Trade Name
- SJM™ FDA UDI
- Generic Name
- Cardiovascular catheter sheath FDA UDI
- Device Name
- REPOSITIONING SLEEVE FDA UDI
- Model / Reference
- 406503 FDA UDI
- Description
- REPOSITIONING SLEEVE FDA UDI
Identifiers
- Catalog Number
- 406503 FDA UDI
- Primary DI / UDI-DI
- 05414734030052 FDA UDI
- 510(k) Number
- K884478 FDA UDI
- FDA Product Code
- DQR FDA UDI
- GMDN Term
- Cardiovascular catheter sheath FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1300 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
Dimensions & Sizes
- Size
- Length — 60 Centimeter FDA UDI
Category: Cardiovascular catheter sheath
Sjm™ by St. Jude Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiovascular catheter sheath.
- Catheter Extender for Yamato Plus IABs - 10 Pack — Datascope Corp. · Class II
- Pounce Sheath — Surmodics, Inc. · Class II
- SJM™ — ST. JUDE MEDICAL, INC. · Class II
- SJM™ — ST. JUDE MEDICAL, INC. · Class II
- SJM™ — ST. JUDE MEDICAL, INC. · Class II
Cleared under the same submission
K884478 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 |
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Manufacturer
- Manufacturer
- St. Jude Medical, Inc.
Sources (1)
- FDA UDI 3672f669-f8a5-4e19-b5cc-5c7e1a93b9bd 38 fields · synced May 31, 2026