The following data is part of a premarket notification filed by I-flow Corp. with the FDA for Intraop Catheter.
| Device ID | K991543 |
| 510k Number | K991543 |
| Device Name: | INTRAOP CATHETER |
| Classification | Pump, Infusion, Elastomeric |
| Applicant | I-FLOW CORP. 20202 WINDROW DR. Lake Forest, CA 92630 |
| Contact | Stanley E Fry |
| Correspondent | Stanley E Fry I-FLOW CORP. 20202 WINDROW DR. Lake Forest, CA 92630 |
| Product Code | MEB |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-03 |
| Decision Date | 1999-10-25 |
| Summary: | summary |