Cleared Traditional

CIPA (ADULTS) CIPI (INFANTS)

K992932 · Dmc Medical, Ltd. · Cardiovascular

Jun 2000

Decision

281d

Days

Class 2

Risk

About This 510(k) Submission

K992932 is an FDA 510(k) clearance for the CIPA (ADULTS) CIPI (INFANTS), a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF), submitted by Dmc Medical, Ltd. (Fullerton, US). The FDA issued a Cleared decision on June 7, 2000, 281 days after receiving the submission on August 31, 1999. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.

Submission Details

510(k) Number	K992932 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 31, 1999
Decision Date	June 07, 2000
Days to Decision	281 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.4210