FDA Product Code
FDA Product Code KOD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5130
510(k) Clearances — 238 records · page 3 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K801784 | URINARY CATHETERS #3400,3410 &3420 | The Healthcare Group Laboratories, Inc. | 1980-08-13 | Traditional | PDF ↗ |
| K800609 | CATHETER STYLET | G.D. Searle and Co. | 1980-04-10 | Traditional | PDF ↗ |
| K800505 | URETHRAL CATHETER | Medi-Craft , Ltd. | 1980-04-08 | Traditional | PDF ↗ |
| K800306 | FOLEY CATHETER | Abco Dealers, Inc. | 1980-02-28 | Traditional | PDF ↗ |
| K800308 | PEDIATRIC FOLEY CATHETER | Abco Dealers, Inc. | 1980-02-28 | Traditional | PDF ↗ |
| K800307 | IRRIGATION (3-WAY) FOLEY CATHETER | Abco Dealers, Inc. | 1980-02-28 | Traditional | PDF ↗ |
| K792719 | 3 WAY URETHRAL IRRIGATION CATHETER | Vesta, Inc. | 1980-01-16 | Traditional | PDF ↗ |
| K792220 | VANCE KIDNEY BIOPSY BRUSHES | Vance Products, Inc. | 1979-12-06 | Traditional | PDF ↗ |
| K791598 | CLOSED SYSTEM FOLEY CATHERIZATION PROCED | Walpak Co. | 1979-11-16 | Traditional | PDF ↗ |
| K792109 | CONPHAR LATEX FOLEY CATH-STERILE | Conphar, Inc. | 1979-11-16 | Traditional | PDF ↗ |
| K792107 | CONPHAR 100% SILICONE FOLEY CATH-STER. | Conphar, Inc. | 1979-11-16 | Traditional | PDF ↗ |
| K792111 | CONPHAR SILICONE COATED FOLEY CATH | Conphar, Inc. | 1979-11-16 | Traditional | PDF ↗ |
| K792038 | NELATON CATHETER | American Hospital Supply Corp. | 1979-11-13 | Traditional | PDF ↗ |
| K792037 | NON-A-THERM | Labarge, Inc. | 1979-11-13 | Traditional | PDF ↗ |
| K791674 | BLADDER RETENTION CATHETERIZATION TRAY | Latex Ind., Inc. | 1979-11-05 | Traditional | PDF ↗ |
| K791992 | DYNACOR STERILE CARELON SILICONE CATH. | Medline Industries, Inc. | 1979-10-26 | Traditional | PDF ↗ |
| K791717 | BARD URODYNAMIC CATHETERS | C.R. Bard, Inc. | 1979-09-17 | Traditional | PDF ↗ |
| K791427 | CATHETERIZATION TRAYS FOLEY AND URETHRAL | Intermed, Inc. | 1979-09-07 | Traditional | PDF ↗ |
| K791244 | CONPHAR FEMALE CATHETER-STERILE | Conphar, Inc. | 1979-09-07 | Traditional | PDF ↗ |
| K791264 | CONPHAR NELATON CATHETER-STERILE | Conphar, Inc. | 1979-08-03 | Traditional | PDF ↗ |
| K791332 | UNIVERSAL FOLEY CATHETER TRAY | Abco Dealers, Inc. | 1979-08-03 | Traditional | PDF ↗ |
| K790728 | TOUCHLESS TM FOLEY CATHETER KIT | Diamed Division Ill. Tool Works, Inc. | 1979-06-01 | Traditional | PDF ↗ |
| K781751 | CATHETER, AKRON FOLEY TEFLON | Latex Ind., Inc. | 1979-01-22 | Traditional | PDF ↗ |
| K781457 | FOLEY CATHETERS | Intermed, Inc. | 1978-09-20 | Traditional | PDF ↗ |
| K760897 | STERILE URETHRAL CATHETER KIT | Diamed Division Ill. Tool Works, Inc. | 1978-08-31 | Traditional | PDF ↗ |
| K780675 | STERILE 100% SILICONE FOLEY CATHETER | Medline Industries, Inc. | 1978-05-09 | Traditional | PDF ↗ |
| K780676 | STERILE CLOSED SYSTEM | Medline Industries, Inc. | 1978-05-09 | Traditional | PDF ↗ |
| K770814 | CATHETER, URETHERAL | C.R. Bard, Inc. | 1977-10-18 | Traditional | PDF ↗ |
| K771779 | CATHETERIZATION SYS. URINARY DRAINAGE | Medical Devices, Inc. | 1977-10-05 | Traditional | PDF ↗ |
| K770562 | HANDLER CATHETER | Janet Beach, Ltd. | 1977-03-24 | Traditional | PDF ↗ |
| K770489 | CATHETER WITH HARD VALVE | Pharmaseal Div., Baxter Healthcare Corp. | 1977-03-21 | Traditional | PDF ↗ |
| K770493 | TRAVACATH | Travenol Laboratories, S.A. | 1977-03-21 | Traditional | PDF ↗ |
| K770256 | CATHETERS, SILICONE COATED | Pharmaseal Div., Baxter Healthcare Corp. | 1977-02-17 | Traditional | PDF ↗ |
| K760858 | RUTNER UNIVERSAL WEDGE CATHETER | Cook, Inc. | 1976-12-06 | Traditional | PDF ↗ |
| K761144 | FEM CATH (URETHRAL CATHETER) | Mallinckrodt Critical Care | 1976-12-06 | Traditional | PDF ↗ |
| K761059 | MALE URINARY CATHETER, EXTERNAL | Intermed, Inc. | 1976-12-02 | Traditional | PDF ↗ |
| K760440 | CATHETER, NATURAL LATEX URETHRAL | Akron Catheter, Inc. | 1976-10-20 | Traditional | PDF ↗ |
| K760259 | CATHETER 3-WAY SILICONE FOLEY | Travenol Laboratories, S.A. | 1976-08-23 | Traditional | PDF ↗ |
Product code KOD · Class II · Gastroenterology, Urology. Data: openFDA.