Atlas FDA

VCI SUCTION/IRRIGATION TUBING SET

FDA 510(k) clearance K934382 · decided 1994-02-01

Clearance details

K-number
K934382
Device name
VCI SUCTION/IRRIGATION TUBING SET
Applicant
Vital Concepts, Inc.
Decision
Substantially Equivalent
Date received
1993-09-09
Decision date
1994-02-01
Days to decision
145 days
Clearance type
Traditional
Product code
JOL
Device class
2
Regulation number
880.6740
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Grand Rapids, MI, US
Third-party review
No
Expedited review
No

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RecordFirmDate
STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014 (K051370)Baxter Healthcare Corp2005-08-12
PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION (K000266)Primary Care Solutions, Inc.2001-07-12
PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION (K000265)Primary Care Solutions, Inc.2001-07-12
WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION (K003402)Welcon, Inc.2001-05-01
STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP (K994321)Automatic Liquid Packaging, Inc.2000-10-25
HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE (K974759)Hydrox Laboratories1998-03-09
HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE (K974758)Hydrox Laboratories1998-03-09
STERILE SALINE FOR CATHETER CARE (K974397)Baxter Healthcare Corp1998-02-10
STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION (K973734)Welcon, Inc.1998-02-05
GERM TRAPPER SUCTION TUBE HOLDER (K972372)Rzv Medical Specialties, Inc.1997-12-11
CPR SUCTION CATHETER KIT (K960216)Custom Pack Reliability1996-04-15
STERILE ISOTONIC SALINE & STERILE WATER (K954442)Medcare Custom Packaging, Inc.1995-12-21

Recalls involving this device

RecordFirmDate
Irrigation aspiration system with double spike tubing and 33 cm probe, latex free, catalog recall (Z-0258-04)Vital Concepts, Inc.2004-07-20
Irrigation aspiration system for Nexhat Dorsey type pumps with 33 cm probe and tubing, lat recall (Z-0259-04)Vital Concepts, Inc.2004-07-20
Reorder # Lapkit 3. Contents: 1- 55060 suction/irrigation valve 2- 30012 insufflation tubi recall (Z-0260-04)Vital Concepts, Inc.2004-07-20
Auto Suture IRRIVAC MAX Suction irrigation sytem with 5 mm, 33 cm probe with double spike recall (Z-0261-04)Vital Concepts, Inc.2004-07-20
Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 recall (Z-0020-04)Vital Concepts, Inc.2003-10-15
Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single recall (Z-0021-04)Vital Concepts, Inc.2003-10-15
HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposabl recall (Z-0022-04)Vital Concepts, Inc.2003-10-15
HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), ste recall (Z-0023-04)Vital Concepts, Inc.2003-10-15
Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation recall (Z-0024-04)Vital Concepts, Inc.2003-10-15
Irrigation Aspiration System for Nezhat Dorsey Type Pumps with 33 cm Probe, and Tubing, Di recall (Z-0025-04)Vital Concepts, Inc.2003-10-15