Cleared Traditional

ASPIRATING NEEDLE, CATALOG CODE #12006

K865079 · Dlp, Inc. · Cardiovascular

Mar 1987

Decision

64d

Days

Class 2

Risk

About This 510(k) Submission

K865079 is an FDA 510(k) clearance for the ASPIRATING NEEDLE, CATALOG CODE #12006, a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF), submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on March 3, 1987, 64 days after receiving the submission on December 29, 1986. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.

Submission Details

510(k) Number	K865079 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 29, 1986
Decision Date	March 03, 1987
Days to Decision	64 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—

Device Classification

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