Identity
- Trade Name
- SHERPA NX BALANCED™ FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- CATH SB63DRIGHTSH SB 6F 3DRGT FDA UDI
- Model / Reference
- SB63DRIGHTSH FDA UDI
- Description
- CATH SB63DRIGHTSH SB 6F 3DRGT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000893248 FDA UDI
- 510(k) Number
- K232190 FDA UDI
- FDA Product Code
- DQY FDA UDI
- GMDN Term
- Vascular guide-catheter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 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
Dimensions & Sizes
- Size
- Catheter Length — 100.0 Centimeter FDA UDICatheter Gauge — 6.0 French FDA UDI
Category: Vascular guide-catheter, single-use
Sherpa Nx Balanced™ by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vascular guide-catheter, single-use.
- Surefire Guiding Catheter — Surefire Medical, Inc. · Class II
- Zebra — QApel Medical, Inc. · Class II
- Mach1™ — Boston Scientific · Class II
- RunWay™ — Boston Scientific · Class II
- Destino Steerable Guiding Sheath — Oscor Inc. · Class II
- Mach1™ — Boston Scientific · Class II
- VISTA BRITE TIP — Cordis Corp. · Class II
- Mach1™ — Boston Scientific · Class II
Cleared under the same submission
K232190 also covers:
- SHERPA NX BALANCED™ — MEDTRONIC, INC.
- SHERPA NX BALANCED™ — MEDTRONIC, INC.
- SHERPA NX BALANCED™ — MEDTRONIC, INC.
- SHERPA NX BALANCED™ — MEDTRONIC, INC.
- SHERPA NX BALANCED™ — MEDTRONIC, INC.
- SHERPA NX BALANCED™ — MEDTRONIC, INC.
- SHERPA NX BALANCED™ — MEDTRONIC, INC.
- SHERPA NX BALANCED™ — MEDTRONIC, INC.
- SHERPA NX BALANCED™ — MEDTRONIC, INC.
- SHERPA NX BALANCED™ — MEDTRONIC, INC.
- SHERPA NX BALANCED™ — MEDTRONIC, INC.
- SHERPA NX BALANCED™ — MEDTRONIC, 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
- Medtronic, Inc.
Sources (1)
- FDA UDI 7cfef410-3f2c-4817-8ef7-ae0419d8ecad 37 fields · synced May 30, 2026