The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Saline/ Contrast Media Infusion Catheter.
| Device ID | K063611 |
| 510k Number | K063611 |
| Device Name: | SALINE/ CONTRAST MEDIA INFUSION CATHETER |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
| Contact | Kevin L Cornwell |
| Correspondent | Kevin L Cornwell UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-03 |
| Decision Date | 2007-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H671MIS50ST1 | K063611 | 000 |
| H671MIS50P1 | K063611 | 000 |