Identity
- Trade Name
- VISTA BRITE TIP FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- GC 6F .070 100CM AL2 90° TIP A FDA UDI
- Model / Reference
- SM7608 FDA UDI
- Description
- GC 6F .070 100CM AL2 90° TIP A FDA UDI
Identifiers
- Catalog Number
- SM7608 FDA UDI
- Primary DI / UDI-DI
- 20705032043554 FDA UDI
- 510(k) Number
- K021593 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vascular guide-catheter, single-use
Vista Brite Tip by Cordis Corp. — 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
K021593 also covers:
- CORDIS — Cordis Corp.
- ENVOY — Cordis Corp.
- ENVOY — Cordis Corp.
- SUPERTORQUE — Cordis Corp.
- SUPERTORQUE — Cordis Corp.
- VISTA BRITE TIP — Cordis Corp.
- VISTA BRITE TIP — Cordis Corp.
- VISTA BRITE TIP — Cordis Corp.
- VISTA BRITE TIP — Cordis Corp.
- VISTA BRITE TIP — Cordis Corp.
- VISTA BRITE TIP — Cordis Corp.
- VISTA BRITE TIP — Cordis Corp.
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
- Cordis Corp.
Sources (1)
- FDA UDI b8e80382-148f-45d5-8274-921407fc66c0 36 fields · synced Jun 8, 2026