Camino Ventricular Needle

FDA 510(k) K920088 · Camino Laboratories, Inc.

Substantially Equivalent

510(k) numberK920088

Submission

Device name
Camino Ventricular Needle
Applicant
Camino Laboratories, Inc.
San Diego, CA, US
Received
January 8, 1992
Decision date
May 1, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HCD – Cannula, Ventricular
Device class
Class I (low risk)
Regulation
21 CFR 882.4060
Specialty
Neurology

Other 510(k)s with product code HCD

510(k)DeviceApplicantDecision
K150660Alcyone MEMS Cannula (AMC) SystemHCD · Traditional Alcyone Lifesciences, Inc.04/16/2015SE
K102101Surgivision MR Compatible Ventricular CannulaHCD · Traditional Surgivision, Inc.01/26/2011SE

More from Surgivision, Inc.

510(k)DeviceDecision
K932769Camino Ventricular Drainage SystemJXG · Traditional 03/30/1995SE
K930222Camino Ventricular Access DeviceJXG · Traditional 04/15/1993SE
K930221Camino Ventricular Transducer AccessoryGWM · Traditional 04/15/1993SE
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 Needle cleared by the FDA?

Camino Ventricular Needle (K920088) received a 510(k) decision of Substantially Equivalent on May 1, 1992, 114 days after the submission was received.

What is the product code of K920088?

The FDA product code is HCD – Cannula, Ventricular, a Class I (low risk) device regulated under 21 CFR 882.4060.