510(k) K945258
- Device
- CATCO URINARY COLLECTION KIT
- Applicant
- CATCO MEDICAL, INC.
- 510(k) number
- K945258
- Product code
- FCN
- Decision
- Substantially Equivalent - Kit With Drugs (SEKD)
- Decision date
- 1995-02-16
- Date received
- 1994-10-28
- Regulation
- 876.5250
- Classification name
- Urinary Drainage Collection Kit, For Indwelling Catheter
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CLYDE N BAKER
- Address
- 9010 Foxland Dr. San Antonio TX US 78230 78230
FDA Registration Numbers#
- 1055236
- 1825146
- 3009086335
- 3019798849
- 3006673317
- 3008502431
- 1018233
- 3007007790
- 3005595283
- 3027645738
- 1060680
- 2011171
- 3011020307
- 9612030
- 1061124
- 3000247987
- 1928237
- 9611024
- 2023344
- 3015337348
- 3003528228
- 3015142721
- 1420054
- 3007697249
- 1422598
- 1647149
- 1123010
- 3016702790
- 3010131137
- 3005273623
- 1043214
- 3004111573
- 1030451
- 1423395
- 2032112
- 1643817
- 1058397
- 3035642068
- 1820334
- 1423537
- 3006082230
- 3015058854
- 9616088
- 3004519921
- 3014498861
- 2029015
- 3033796870
- 2320762
- 1054241
- 3004127962
- 3007608536
- 3007329020
- 3009888344
- 3022555975
- 3014637079
- 3014195785
- 1921846
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FCN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K951443 | STANDARD FOLEY SYSTEM PAK | Trinity Laboratories, Inc. | 1995-06-15 |
| K915166 | MICROCYCLER | Medical Inventors Corp., Inc. | 1994-09-07 |
| K922346 | FEMALE URINE SAMPLING DEVICE | Mentor Corp. | 1992-08-14 |
| K890096 | BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG | Medical Inventors Corp., Inc. | 1989-07-14 |
| K883886 | DOUBLE CLOSED URINARY DRAINAGE SYSTEM | Knight Medical, Inc. | 1988-12-19 |
| K883610 | LAKE FOLEY CATHETERIZATION TRAY | Lake Medical Products, Inc. | 1988-10-12 |
| K780134 | URINARY DRAINAGE MONITORING SYSTEM | Medical Devices, Inc. | 1978-02-02 |
| K772133 | URINE SPECIMEN COLLECTING DEVICE | Kendall Research Center | 1977-11-28 |
| K771210 | UROGARD URINARY DRAINAGE BAG | Terumo America, Inc. | 1977-07-11 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases