Identity
- Trade Name
- Innervision FDA UDI
- Generic Name
- Intracerebral infusion/drainage catheter, long-term FDA UDI
- Device Name
- CATH 27065 G VENT SNAP ENDO 10CM FDA UDI
- Model / Reference
- 27065 G FDA UDI
- Description
- CATH 27065 G VENT SNAP ENDO 10CM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169483842 FDA UDI
- 510(k) Number
- K983331 FDA UDI
- FDA Product Code
- LKG FDA UDI
- GMDN Term
- Intracerebral infusion/drainage catheter, long-term FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5550 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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 — 10.0 Centimeter FDA UDI
Category: Intracerebral infusion/drainage catheter, long-term
A comprehensive medical device directory listing the Innervision intracerebral infusion/drainage catheter, a sterile, flexible tube for long-term subdural access to the brain. This device is used for measurement of intracranial pressure (ICP) and as part of a shunt system.
Similar devices
Also classified as Intracerebral infusion/drainage catheter, long-term.
- Phoenix Neuro — Sophysa SA · Class II
- Natus® — Natus Medical Incorporated · Class II
- CODMAN® BACTISEAL® — Integra LifeSciences Production Corporation · Class II
- Phoenix Neuro — Sophysa SA · Class II
- CODMAN® ACCU-FLO® — Integra LifeSciences Production Corporation · Class II
- CODMAN® HOLTER® — Integra LifeSciences Production Corporation · Class II
- Natus® — Natus Medical Incorporated · Class II
- Phoenix Neuro — Sophysa SA · Class II
Cleared under the same submission
K983331 also covers:
- Innervision — Medtronic PS Medical
- Innervision — Medtronic PS Medical
- Innervision — Medtronic PS Medical
- Innervision — Medtronic PS Medical
- Innervision — Medtronic PS Medical
- Innervision — Medtronic PS Medical
- Innervision — Medtronic PS Medical
- Innervision — Medtronic PS Medical
- Innervision — Medtronic PS Medical
- Innervision — Medtronic PS Medical
- Innervision — Medtronic PS Medical
- Innervision — Medtronic PS Medical
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 PS Medical
Sources (1)
- FDA UDI bbe5b1c1-f286-4c09-9616-699e63d13afe 36 fields · synced Jun 27, 2026