Identity
- Trade Name
- CORDIS FDA UDI
- Generic Name
- Haemostasis valve FDA UDI
- Device Name
- ACCS OBTURATOR 6F 13.5CM FDA UDI
- Model / Reference
- 502191 FDA UDI
- Description
- ACCS OBTURATOR 6F 13.5CM FDA UDI
Identifiers
- Catalog Number
- 502191 FDA UDI
- Primary DI / UDI-DI
- 10705032009621 FDA UDI
- 510(k) Number
- K914352 FDA UDI
- FDA Product Code
- DYB FDA UDI
- GMDN Term
- Haemostasis valve 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
Category: Haemostasis valve
Cordis by Cordis US Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Honor® — Merit Medical Systems, Inc. · Class II
- AVANTI — Cordis Corp. · Class II
Cleared under the same submission
K914352 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 |
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Manufacturer
- Manufacturer
- Cordis US Corp.
Sources (1)
- FDA UDI 59892752-6be0-40bd-9e8a-8b2e782e2120 35 fields · synced May 30, 2026