510(k) K890310
- Device
- STERILE FOLEY CATHETER
- Applicant
- KOSAN FAR EAST ENT. LTD.
- 510(k) number
- K890310
- Product code
- EYC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-11-30
- Date received
- 1989-01-23
- Regulation
- 876.5130
- Classification name
- Catheter, Upper Urinary Tract
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- SHOZO SAITO
- Address
- Rm. 1606 Sino Centre 582-592 Nathan Rd. Kowloon Hong Kong TW
FDA Registration Numbers#
- 9613793
- 9616088
- 1054241
- 1061124
- 1043214
- 3004111573
- 1055236
- 2320762
- 8030107
- 3010838917
- 1423537
- 3005483737
- 2025851
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EYC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K200757 | Foley Catheter with Temperature Sensor | Deroyal Industries, Inc. | 2020-10-15 |
| K061918 | FOLEY CATHETERS WITH TEMPERATURE PROBE | GE Healthcare | 2006-08-18 |
| K041416 | EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER | Deroyal | 2004-07-02 |
| K925790 | EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S | Deroyal Industries, Inc. | 1993-05-17 |
Legacy Summary#
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
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