TUBING CONNECTORS EC-2XXX SERIES

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

GISH BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Tubing Connectors Ec-2xxx Series.

Pre-market Notification Details

• Device ID: K833322
• 510k Number: K833322
• Device Name: TUBING CONNECTORS EC-2XXX SERIES
• Classification: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
• Applicant: GISH BIOMEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: DTL
• CFR Regulation Number: 870.4290 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-09-26
• Decision Date: 1983-12-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10803622103145	K833322	000
10803622103367	K833322	000
10803622103374	K833322	000
10803622103381	K833322	000
10803622103398	K833322	000
10803622103404	K833322	000
10803622103411	K833322	000
10803622103428	K833322	000
10803622103435	K833322	000
10803622103442	K833322	000
10803622103466	K833322	000
10803622103473	K833322	000
10803622103480	K833322	000
10803622106528	K833322	000
10803622103350	K833322	000
10803622103343	K833322	000
10803622103336	K833322	000
10803622103152	K833322	000
10803622103169	K833322	000
10803622103176	K833322	000
10803622103190	K833322	000
10803622103206	K833322	000
10803622103213	K833322	000
10803622103244	K833322	000
10803622103251	K833322	000
10803622103268	K833322	000
10803622103275	K833322	000
10803622103282	K833322	000
10803622103299	K833322	000
10803622103312	K833322	000
10803622106535	K833322	000
10803622106542	K833322	000
10803622106559	K833322	000
10803622123303	K833322	000
10803622123310	K833322	000
10803622123327	K833322	000
10803622123334	K833322	000
10803622123341	K833322	000
10803622123358	K833322	000
10803622123365	K833322	000
10803622123372	K833322	000
10803622123389	K833322	000
10803622123396	K833322	000
10803622123402	K833322	000
10803622128384	K833322	000
10803622128391	K833322	000
10803622123297	K833322	000
10803622123280	K833322	000
10803622123273	K833322	000
10803622106566	K833322	000
10803622123150	K833322	000
10803622123167	K833322	000
10803622123174	K833322	000
10803622123181	K833322	000
10803622123198	K833322	000
10803622123204	K833322	000
10803622123211	K833322	000
10803622123228	K833322	000
10803622123235	K833322	000
10803622123242	K833322	000
10803622123259	K833322	000
10803622123266	K833322	000
10803622129275	K833322	000