Cleared Traditional

C-DAK 3500

K770535 · Cordis Corp. · Gastroenterology & Urology
Apr 1977
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K770535 is an FDA 510(k) clearance for the C-DAK 3500, a Clamp, Tubing, Blood, Automatic (Class II — Special Controls, product code FIG), submitted by Cordis Corp. (Mchenry, US). The FDA issued a Cleared decision on April 15, 1977, 25 days after receiving the submission on March 21, 1977. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number K770535 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 1977
Decision Date April 15, 1977
Days to Decision 25 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code FIG — Clamp, Tubing, Blood, Automatic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5820

More from Cordis Corp.

View all
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM
K130981 · FGE · Mar 2014
POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
K112797 · LIT · May 2012
ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE
K101651 · NTE · Jul 2010
MICRO GUIDE CATHETER XP
K082143 · PDU · Aug 2008
SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB
K062798 · FGE · Feb 2008