The following data is part of a premarket notification filed by I-flow Corp. with the FDA for On-q Introducers.
| Device ID | K063234 |
| 510k Number | K063234 |
| Device Name: | ON-Q INTRODUCERS |
| 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-25 |
| Decision Date | 2006-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10193494136977 | K063234 | 000 |
| 30680651135439 | K063234 | 000 |
| 30680651135446 | K063234 | 000 |
| 30680651135453 | K063234 | 000 |
| 30680651135460 | K063234 | 000 |
| 30680651136924 | K063234 | 000 |
| 30680651136931 | K063234 | 000 |
| 30680651136948 | K063234 | 000 |
| 30680651136955 | K063234 | 000 |
| 10193494310001 | K063234 | 000 |
| 10193494309999 | K063234 | 000 |
| 10193494135444 | K063234 | 000 |
| 10193494135451 | K063234 | 000 |
| 10193494135468 | K063234 | 000 |
| 10193494137349 | K063234 | 000 |
| 10193494137356 | K063234 | 000 |
| 10193494137363 | K063234 | 000 |
| 10193494137387 | K063234 | 000 |
| 10193494137394 | K063234 | 000 |
| 30680651136962 | K063234 | 000 |
| 30680651136979 | K063234 | 000 |
| 10193494135826 | K063234 | 000 |
| 10193494135833 | K063234 | 000 |
| 10193494135840 | K063234 | 000 |
| 10193494136922 | K063234 | 000 |
| 10193494136939 | K063234 | 000 |
| 10193494136946 | K063234 | 000 |
| 10193494136953 | K063234 | 000 |
| 10193494136960 | K063234 | 000 |
| 10193494135819 | K063234 | 000 |
| 10193494135772 | K063234 | 000 |
| 30680651137341 | K063234 | 000 |
| 30680651137358 | K063234 | 000 |
| 30680651137365 | K063234 | 000 |
| 30680651137389 | K063234 | 000 |
| 30680651137396 | K063234 | 000 |
| 30680651309991 | K063234 | 000 |
| 30680651310003 | K063234 | 000 |
| 10193494135765 | K063234 | 000 |
| 10193494135437 | K063234 | 000 |