510(k) K830359 ยท KOD Catheter, Urological
STERILE CATHERIZATION PROCEDURE TRAYS
| Applicant | Welcon, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Mar 17, 1983 |
| Received | Feb 3, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K830359
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Nurse 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 |
KOD | None listed |
| Jan 11, 2012 | Nurse 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 |
KOD | None listed |
| Jan 11, 2012 | Nurse 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 |
KOD | None listed |
| Jan 11, 2012 | Nurse 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 |
KOD | None listed |
| Jan 11, 2012 | Nurse 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 |
KOD | None listed |
| Jan 11, 2012 | Nurse 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 |
KOD | None listed |
| Jan 11, 2012 | Nurse 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 |
KOD | None listed |
| Jan 11, 2012 | Nurse 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 |
KOD | None listed |
| Jan 11, 2012 | Nurse 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 |
KOD | None listed |
| Jan 11, 2012 | Nurse 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 |
KOD | None listed |
| Jan 11, 2012 | Nurse 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 |
KOD | None listed |
| Jan 11, 2012 | Nurse 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 |
KOD | None listed |
| Jan 11, 2012 | Nurse 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 |
KOD | None listed |
| Jan 11, 2012 | Nurse 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 |
KOD | None listed |
| Jan 11, 2012 | Nurse 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 |
KOD | None listed |
| Jan 11, 2012 | Nurse 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 |
KOD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.