Identity
- Trade Name
- Multiflex FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- A steerable, sterile, single-use, percutaneous introducer sheath with dilator used to facilitate placement of various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. FDA UDI
- Model / Reference
- VIZ125D FDA UDI
- Description
- A steerable, sterile, single-use, percutaneous introducer sheath with dilator used to facilitate placement of various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. FDA UDI
Identifiers
- Primary DI / UDI-DI
- G44VIZ125D0 FDA UDI
- 510(k) Number
- K221655 FDA UDI
- FDA Product Code
- DYB FDA UDI
- GMDN Term
- Vascular guide-catheter, 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
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
- Catheter Inner Diameter — 4.28 Millimeter FDA UDI
Category: Vascular guide-catheter, single-use
Multiflex by Vizaramed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vascular guide-catheter, single-use.
- Launcher — MEDTRONIC, INC. · Class II
- Launcher™ — MEDTRONIC, INC. · Class II
- SHERPA NX BALANCED — MEDTRONIC, INC. · Class II
- Surefire Guiding Catheter — Surefire Medical, Inc. · Class II
- SHERPA NX BALANCED™ — MEDTRONIC, INC. · Class II
- Zebra — QApel Medical, Inc. · Class II
- Mach1™ — Boston Scientific · Class II
- SHERPA NX BALANCED — MEDTRONIC, INC. · Class II
Cleared under the same submission
K221655 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vizaramed, Inc.
Sources (1)
- FDA UDI 342a2a7a-8af8-4d37-bb8f-cf61ae91e5f9 37 fields · synced May 31, 2026