The following data is part of a premarket notification filed by I-flow Corp. with the FDA for On-q Catheter, On-antimicrobial Catheter, Soaker Catheter, I-flow Catheter.
| Device ID | K051401 |
| 510k Number | K051401 |
| Device Name: | ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-31 |
| Decision Date | 2005-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10193494449503 | K051401 | 000 |
| 10193494135338 | K051401 | 000 |
| 10193494135352 | K051401 | 000 |
| 10193494135376 | K051401 | 000 |
| 10193494135390 | K051401 | 000 |
| 10193494135413 | K051401 | 000 |
| 10193494449411 | K051401 | 000 |
| 10193494449428 | K051401 | 000 |
| 10193494449473 | K051401 | 000 |
| 10193494449480 | K051401 | 000 |
| 10193494135420 | K051401 | 000 |