Camino Ventricular Access Device

FDA 510(k) K930222 · Camino Laboratories, Inc.

Substantially Equivalent

510(k) numberK930222

Submission

Device name
Camino Ventricular Access Device
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

Official FDA 510(k) record

Device classification

Product code
JXG – Shunt, Central Nervous System And Components
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5550
Specialty
Neurology
Implant
Yes

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More from Aesculap, Inc.

510(k)DeviceDecision
K932769Camino Ventricular Drainage SystemJXG · Traditional 03/30/1995SE
K930221Camino Ventricular Transducer AccessoryGWM · Traditional 04/15/1993SE
K920088Camino Ventricular NeedleHCD · Traditional 05/01/1992SE
K914735Ventricular Pressure Monitoring Kit, Model 110-4HMGWM · Traditional 01/17/1992SE
K912833Camino Model M420: Monit Inter W/Mean Pres DisplayDSK · Traditional 09/23/1991SE
K893232Model V420 Direct Pressure Monitor & 427 WaveformDSK · Traditional 07/14/1989SE
K881183Ventricular Bolt Pressure Monitoring Kit #110-4HGWM · Traditional 05/04/1988SE
K863969Camino Compartmental Press Monitor CATH/110-4DDXO · Traditional 05/27/1987SE
K861961Camino CSF Drainage System Model 040JXG · Traditional 08/12/1986SE
K862160Camino Hand Drill - Model 030HBG · Traditional 07/18/1986SE

Questions and answers

When was Camino Ventricular Access Device cleared by the FDA?

Camino Ventricular Access Device (K930222) 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 K930222?

The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.