Identity
- Trade Name
- Pro-Flo XT™ FDA UDI
- Generic Name
- Angiographic catheter, single-use FDA UDI
- Device Name
- CATH 010351 PF 10PK 6F 100 R BYP ST XT FDA UDI
- Model / Reference
- 010351 FDA UDI
- Description
- CATH 010351 PF 10PK 6F 100 R BYP ST XT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994941534 FDA UDI
- 510(k) Number
- K960056 FDA UDI
- FDA Product Code
- DQO FDA UDI
- GMDN Term
- Angiographic catheter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1200 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 Gauge — 6.0 French FDA UDILength — 100.0 Centimeter FDA UDILumen/Inner Diameter — 1.27 Millimeter FDA UDI
Category: Angiographic catheter, single-use
Pro-Flo XT™ by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Angiographic catheter, single-use.
- INFINITI — Cordis US Corp. · Class II
- Performa® — Merit Medical Systems, Inc. · Class II
- Performa® — Merit Medical Systems, Inc. · Class II
- Torcon NB — COOK INCORPORATED · Class II
- Performa® — Merit Medical Systems, Inc. · Class II
- ConcierGE Guiding Excellence™ — Merit Medical Systems, Inc. · Class II
- INFINITI — Cordis US Corp. · Class II
- CXI — COOK INCORPORATED · Class II
Cleared under the same submission
K960056 also covers:
- PRO-FLO™ — MEDTRONIC, INC.
- Pro-Flo XT™ — MEDTRONIC, INC.
- Pro-Flo XT™ — MEDTRONIC, INC.
- Pro-Flo XT™ — MEDTRONIC, INC.
- Pro-Flo XT™ — MEDTRONIC, INC.
- Pro-Flo XT™ — MEDTRONIC, INC.
- Pro-Flo XT™ — MEDTRONIC, INC.
- Pro-Flo XT™ — MEDTRONIC, INC.
- Pro-Flo XT™ — MEDTRONIC, INC.
- Pro-Flo XT™ — MEDTRONIC, INC.
- Pro-Flo XT™ — MEDTRONIC, INC.
- Pro-Flo XT™ — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI 9c252996-8fb7-4e39-8f00-aaa5a4e267b5 37 fields · synced May 30, 2026