Cleared Traditional

K920088 - CAMINO VENTRICULAR NEEDLE (FDA 510(k) Clearance)

May 1992
Decision
114d
Days
Class 1
Risk

K920088 is an FDA 510(k) clearance for the CAMINO VENTRICULAR NEEDLE. This device is classified as a Cannula, Ventricular (Class I - General Controls, product code HCD).

Submitted by Camino Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on May 1, 1992, 114 days after receiving the submission on January 8, 1992.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4060.

Submission Details

510(k) Number K920088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1992
Decision Date May 01, 1992
Days to Decision 114 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code HCD — Cannula, Ventricular
Device Class Class I - General Controls
CFR Regulation 21 CFR 882.4060