The following data is part of a premarket notification filed by I-flow Corp. with the FDA for Modification To Soaker Catheter.
| Device ID | K043456 |
| 510k Number | K043456 |
| Device Name: | MODIFICATION TO SOAKER CATHETER |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | I-FLOW CORP. 20202 WINDROW DR. Lake Forest, CA 92630 |
| Contact | Shane Noehre |
| Correspondent | Shane Noehre I-FLOW CORP. 20202 WINDROW DR. Lake Forest, CA 92630 |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-15 |
| Decision Date | 2005-01-11 |
| Summary: | summary |