DTL · Class II · 21 CFR 870.4290

FDA Product Code DTL: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Leading manufacturers include Merit Medical Systems, Inc., Texas Medical Products, Inc. and North American Instrument Corp..

137
Total
137
Cleared
94d
Avg days
1976
Since
137 devices
73–96 of 137
Cleared Aug 03, 1989
SARNS PRESSURE ADJUSTABLE SAFETY SYSTEM
K893683
3M Company
Cardiovascular · 79d
Cleared Jul 24, 1989
ANGIOGRAPHY CUSTOM PACKS
K891572
Procedure Packs, Inc.
Cardiovascular · 126d
Cleared Jul 14, 1989
DISPOSABLE TRANSDUCER MANIFOLD
K890676
L.O.N. Research, Inc.
Cardiovascular · 155d
Cleared Apr 19, 1989
LIPID STOPCOCK
K890580
North American Instrument Corp.
Cardiovascular · 72d
Cleared Jan 12, 1989
NAMIC DUAL BACKCHECK VALVE
K884408
North American Instrument Corp.
Cardiovascular · 85d
Cleared Dec 28, 1988
PROCEDURE PACKS CONTRAST MEDIA SETS
K882717
Procedure Packs, Inc.
Cardiovascular · 180d
Cleared Dec 05, 1988
USCI TANDEM ADAPTER
K884200
C.R. Bard, Inc.
Cardiovascular · 60d
Cleared Oct 28, 1988
BIO-MEDICUS TUBING CONNECTORS
K883956
Bio Medicus, Inc.
Cardiovascular · 39d
Cleared May 10, 1988
LARGE LUMEN Y ADAPTER W/ROTATING DEVICE
K880831
Interventional Medical, Inc.
Cardiovascular · 70d
Cleared Jan 19, 1988
ROTATING HEMOSTATIC VALVE
K873971
Target Therapeutics
Cardiovascular · 112d
Cleared Oct 07, 1987
SILENT GUARD CAT. NO. SG-10
K873488
American Omni Medical, Inc.
Cardiovascular · 37d
Cleared Aug 12, 1987
DIDECO-SHILEY PREASSEMBLED SURGICAL WASH SET
K872161
Shiley, Inc.
Cardiovascular · 69d
Cleared Apr 27, 1987
#014160-TAB TUBING ROTATOR ADAPTOR
K870325
Clinical Connections, Inc.
Cardiovascular · 89d
Cleared Feb 20, 1987
MANIFOLD SWIVEL ROTATOR MODELS 014320 & 014321-TAB
K870073
Clinical Connections, Inc.
Cardiovascular · 43d
Cleared Oct 31, 1986
LUER LOCK SKIRT
K862451
Hewlett-Packard Co.
Cardiovascular · 126d
Cleared Oct 22, 1986
MEDI-PLAST DISPOSABLE MANIFOLD
K863402
Medi-Plast Intl., Inc.
Cardiovascular · 49d
Cleared Oct 15, 1986
CORDIS ANGIOPLASTY HEMOSTASIS DEVICES
K863177
Cordis Corp.
Cardiovascular · 58d
Cleared Sep 29, 1986
MEDCOMP DISPOSABLE MANIFOLD SYSTEM
K863661
Medical Components, Inc.
Cardiovascular · 11d
Cleared Jul 17, 1986
DISPOSABLE STOPCOCK
K861783
Utah Medical Products, Inc.
Cardiovascular · 70d
Cleared Mar 31, 1986
TUBING CONNECTORS
K860291
Biomedical Exports, Inc.
Cardiovascular · 62d
Cleared Feb 10, 1986
DISPOSABLE MANIFOLD
K854960
Utah Medical Products, Inc.
Cardiovascular · 61d
Cleared Jan 13, 1986
CUSTOM CORONARY MANIFOLD KITS
K853749
Procedure Products, Inc.
Cardiovascular · 126d
Cleared Jan 08, 1986
HEMOSTATIC SIDEARM
K854397
Target Therapeutics
Cardiovascular · 69d
Cleared Dec 11, 1985
ARTERIAL/VENOUS SAMPLE LINE BOS-CMSL
K853950
American Bentley
Cardiovascular · 77d