The following data is part of a premarket notification filed by The Flume Catheter Company, Ltd. with the FDA for Flume Catheter.
| Device ID | K212151 |
| 510k Number | K212151 |
| Device Name: | FLUME Catheter |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | The Flume Catheter Company, Ltd. The Granary, Millhouse Frensham, GB Gu10 3ee |
| Contact | Roger Holmes |
| Correspondent | Elaine Duncan Paladin Medical, Inc. PO Box 560 Stillwater, MN 55082 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-09 |
| Decision Date | 2021-11-03 |