Identity
- Trade Name
- TrailBlazer™ Angled FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- PS ASC-035-090 TRAILBLAZER ANGLED V03 FDA UDI
- Model / Reference
- ASC-035-090 FDA UDI
- Description
- PS ASC-035-090 TRAILBLAZER ANGLED V03 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000104719 FDA UDI
- 510(k) Number
- K162384 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 Gauge — 4.0 French FDA UDIOuter Diameter — 1.04 Millimeter FDA UDILength — 90.0 Centimeter FDA UDI
Category: Vascular guide-catheter, single-use
TrailBlazer™ Angled by Covidien LP — 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
K162384 also covers:
- TrailBlazer™ Angled — Covidien LP
- TrailBlazer™ Angled — Covidien LP
- TrailBlazer™ Angled — Covidien LP
- TrailBlazer™ Angled — Covidien LP
- TrailBlazer™ Angled — Covidien LP
- TrailBlazer™ Angled — Covidien LP
- TrailBlazer™ Angled — Covidien LP
- TrailBlazer™ Angled — Covidien LP
- TrailBlazer™ Angled — Covidien LP
- TrailBlazer™ Angled — Covidien LP
- TrailBlazer™ Angled — Covidien LP
- TrailBlazer™ Angled — Covidien LP
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
- Covidien LP
Sources (1)
- FDA UDI 83bdf65f-cf73-4eb5-9dee-dd7ce7530a53 37 fields · synced May 30, 2026