Cleared Traditional

COAXIAL CATHETER SET

K902694 · Cook Ob/Gyn · Obstetrics & Gynecology
Aug 1990
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K902694 is an FDA 510(k) clearance for the COAXIAL CATHETER SET, a Cap, Cervical (Class II — Special Controls, product code HDR), submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on August 28, 1990, 70 days after receiving the submission on June 19, 1990. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5250.

Submission Details

510(k) Number K902694 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 1990
Decision Date August 28, 1990
Days to Decision 70 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code HDR — Cap, Cervical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5250