Identity
- Trade Name
- ZUMA® FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- CATHETER ZM6AL105 ZM 6F 5PK 100 AL10 FDA UDI
- Model / Reference
- ZM6AL105 FDA UDI
- Description
- CATHETER ZM6AL105 ZM 6F 5PK 100 AL10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994785961 FDA UDI
- 510(k) Number
- K981198 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
- Not 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
- Length — 100.0 Centimeter FDA UDICatheter Gauge — 6.0 French FDA UDI
Zuma® by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K981198 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
- Medtronic, Inc.
Sources (1)
- FDA UDI eba73948-2ab7-47ea-89ed-cc48fffc7743 38 fields · synced Jun 8, 2026