The following data is part of a premarket notification filed by Rusch Intl. with the FDA for Rusch Brillant Silicone Foley Catheter.
| Device ID | K972184 |
| 510k Number | K972184 |
| Device Name: | RUSCH BRILLANT SILICONE FOLEY CATHETER |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 |
| Contact | James R Whitney |
| Correspondent | James R Whitney RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-10 |
| Decision Date | 1998-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704307979 | K972184 | 000 |
| 44026704308031 | K972184 | 000 |
| 24026704308020 | K972184 | 000 |
| 24026704308013 | K972184 | 000 |
| 44026704308000 | K972184 | 000 |
| 44026704307997 | K972184 | 000 |
| 24026704307986 | K972184 | 000 |
| 44026704307966 | K972184 | 000 |
| 24026704022131 | K972184 | 000 |
| 44026704022128 | K972184 | 000 |
| 44026704022111 | K972184 | 000 |
| 24026704334883 | K972184 | 000 |
| 44026704334870 | K972184 | 000 |
| 24026704334869 | K972184 | 000 |
| 44026704334856 | K972184 | 000 |
| 44026704308048 | K972184 | 000 |
| 24026704308051 | K972184 | 000 |
| 44026704547300 | K972184 | 000 |
| 24026704335071 | K972184 | 000 |
| 44026704335068 | K972184 | 000 |
| 24026704335057 | K972184 | 000 |
| 24026704335040 | K972184 | 000 |
| 44026704335037 | K972184 | 000 |
| 24026704335026 | K972184 | 000 |
| 24026704335019 | K972184 | 000 |
| 44026704335006 | K972184 | 000 |
| 44026704334993 | K972184 | 000 |
| 24026704334982 | K972184 | 000 |
| 44026704334979 | K972184 | 000 |
| 24026704334968 | K972184 | 000 |
| 44026704334955 | K972184 | 000 |
| 24026704105711 | K972184 | 000 |