The following data is part of a premarket notification filed by Sewoon Medical Co., Ltd. with the FDA for All-silicone Foley Balloon Catheter (two Way; Three Way, Radiopaque).
| Device ID | K013276 |
| 510k Number | K013276 |
| Device Name: | ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE) |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | SEWOON MEDICAL CO., LTD. PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm SEWOON MEDICAL CO., LTD. PO BOX 7007 Deerfield, IL 60015 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-01 |
| Decision Date | 2002-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806369403603 | K013276 | 000 |
| 08806369402507 | K013276 | 000 |
| 08806369402002 | K013276 | 000 |
| 08806369400626 | K013276 | 000 |
| 08806369400602 | K013276 | 000 |
| 08806369400589 | K013276 | 000 |
| 08806369400565 | K013276 | 000 |
| 08806369400541 | K013276 | 000 |
| 08806369400527 | K013276 | 000 |
| 08806369400503 | K013276 | 000 |
| 08806369402521 | K013276 | 000 |
| 08806369402545 | K013276 | 000 |
| 08806369402569 | K013276 | 000 |
| 08806369403108 | K013276 | 000 |
| 08806369403085 | K013276 | 000 |
| 08806369403061 | K013276 | 000 |
| 08806369403047 | K013276 | 000 |
| 08806369403023 | K013276 | 000 |
| 08806369403009 | K013276 | 000 |
| 08806369402620 | K013276 | 000 |
| 08806369402606 | K013276 | 000 |
| 08806369402583 | K013276 | 000 |
| 08806369400008 | K013276 | 000 |