ClearanceBrief
510(k) K830359 ยท KOD Catheter, Urological

STERILE CATHERIZATION PROCEDURE TRAYS

ApplicantWelcon, Inc., Mchenry IL, US
DecisionSubstantially Equivalent, Mar 17, 1983
ReceivedFeb 3, 1983
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K830359

DateFirm and productCodeLinked 510(k)
Jan 11, 2012Nurse Assist, Inc
McKESSON Medi-Pak Urethral Catheter Tray with Plastic Catheter Sterile.Single Use.Disposable.Latex-Free 20 Trays Per Case Reorder No. 37-231 Marketed by McKesson Corporation McKesson Medical-Surgical,
Terminated
KODNone listed
Jan 11, 2012Nurse Assist, Inc
McKESSON Medi-Pak Urethral Catheter Tray with Red Rubber Catheter Sterile.Single Use.Disposable 20 Trays Per Case Reorder No. 37-232 CAUTION: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE
Terminated
KODNone listed
Jan 11, 2012Nurse Assist, Inc
McKESSON Medi-Pak Foley Catheter Tray without Catheter For Use With 30 cc Foley Catheter Sterile.Single Use.Disposable.Latex-Free 20 Trays Per Case Reorder No. 37-234 Marketed by McKesson Corporation
Terminated
KODNone listed
Jan 11, 2012Nurse Assist, Inc
WELCON TM BRAND REORDER NO. 7300 (STERILE) URETHRAL CATHETER TRAY w/o Plastic Catheter 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.c
Terminated
KODNone listed
Jan 11, 2012Nurse Assist, Inc
WELCON TM BRAND REORDER NO. 7301 (STERILE) URETHRAL CATHETER TRAY w/ Plastic Catheter 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.co
Terminated
KODNone listed
Jan 11, 2012Nurse Assist, Inc
WELCON TM BRAND REORDER NO. 7302 (STERILE) URETHRAL CATHETER TRAY w/ Red Rubber Catheter Caution: Contains Natural Latex 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort
Terminated
KODNone listed
Jan 11, 2012Nurse Assist, Inc
WELCON TM BRAND REORDER NO. 7303 (STERILE) FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 ww
Terminated
KODNone listed
Jan 11, 2012Nurse Assist, Inc
WELCON TM BRAND REORDER NO. 7304 (STERILE) FOLEY CATHETER TRAY w/o Catheter w/30ml. Prefilled Syringe 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 ww
Terminated
KODNone listed
Jan 11, 2012Nurse Assist, Inc
WELCON TM BRAND REORDER NO. 7305 (STERILE) FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 ww
Terminated
KODNone listed
Jan 11, 2012Nurse Assist, Inc
WELCON TM BRAND REORDER NO. 7401 (STERILE) URETHRAL CATHETER KIT With 3 Compartment Plastic Pouch. LOT 25 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 w
Terminated
KODNone listed
Jan 11, 2012Nurse Assist, Inc
WELCON TM BRAND REORDER NO. 7402 (STERILE) URETHRAL CATHETER KIT (Female) 25 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com URETHRAL
Terminated
KODNone listed
Jan 11, 2012Nurse Assist, Inc
WELCON TM BRAND REORDER NO. 8012 (STERILE) CATHETER CARE KIT 60 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com CATHETER CARE KIT
Terminated
KODNone listed
Jan 11, 2012Nurse Assist, Inc
REF UT7010 Catheter Insertion Tray 10cc Pre-Filled Syringe with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERI
Terminated
KODNone listed
Jan 11, 2012Nurse Assist, Inc
REF UT7030 Catheter Insertion Tray 30cc Pre-Filled Syringe with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERI
Terminated
KODNone listed
Jan 11, 2012Nurse Assist, Inc
REF UT8140 Urethal Insertion Tray Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERILE EO Distributed by: Coloplast Corp. Mi
Terminated
KODNone listed
Jan 11, 2012Nurse Assist, Inc
REF UT8150 Urethal Insertion Tray 14Fr Red Rubber Catheter with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERI
Terminated
KODNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.