Camino Ventricular Transducer Accessory
FDA 510(k) K930221 · Camino Laboratories, Inc.
510(k) numberK930221
Submission
- Device name
- Camino Ventricular Transducer Accessory
- Applicant
- Camino Laboratories, Inc.
San Diego, CA, US - Received
- January 15, 1993
- Decision date
- April 15, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K182073 | BcSs-PICNI-2000 SensorGWM · Traditional | Braincare Desenvolvimento E Inovacao Tecnologica… | 10/17/2019SE |
More from Braincare Desenvolvimento E Inovacao Tecnologica S.A.
| 510(k) | Device | Decision |
|---|---|---|
| K932769 | Camino Ventricular Drainage SystemJXG · Traditional | 03/30/1995SE |
| K930222 | Camino Ventricular Access DeviceJXG · Traditional | 04/15/1993SE |
| K920088 | Camino Ventricular NeedleHCD · Traditional | 05/01/1992SE |
| K914735 | Ventricular Pressure Monitoring Kit, Model 110-4HMGWM · Traditional | 01/17/1992SE |
| K912833 | Camino Model M420: Monit Inter W/Mean Pres DisplayDSK · Traditional | 09/23/1991SE |
| K893232 | Model V420 Direct Pressure Monitor & 427 WaveformDSK · Traditional | 07/14/1989SE |
| K881183 | Ventricular Bolt Pressure Monitoring Kit #110-4HGWM · Traditional | 05/04/1988SE |
| K863969 | Camino Compartmental Press Monitor CATH/110-4DDXO · Traditional | 05/27/1987SE |
| K861961 | Camino CSF Drainage System Model 040JXG · Traditional | 08/12/1986SE |
| K862160 | Camino Hand Drill - Model 030HBG · Traditional | 07/18/1986SE |
Questions and answers
When was Camino Ventricular Transducer Accessory cleared by the FDA?
Camino Ventricular Transducer Accessory (K930221) received a 510(k) decision of Substantially Equivalent on April 15, 1993, 90 days after the submission was received.
What is the product code of K930221?
The FDA product code is GWM – Device, Monitoring, Intracranial Pressure, a Class II (moderate risk) device regulated under 21 CFR 882.1620.