The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Peripherally Inserted Central Catheter.
| Device ID | K001874 |
| 510k Number | K001874 |
| Device Name: | PERIPHERALLY INSERTED CENTRAL CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| 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 | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-20 |
| Decision Date | 2000-09-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H671PA7011 | K001874 | 000 |
| H671PB3PS0 | K001874 | 000 |
| H671PB3PP0 | K001874 | 000 |
| H671PB3LPS0 | K001874 | 000 |
| H671PB2PS0 | K001874 | 000 |
| H671PB2PP0 | K001874 | 000 |
| H671PB2LPS0 | K001874 | 000 |
| H671P2S1 | K001874 | 000 |
| H671P2P1 | K001874 | 000 |
| H671P2LS1 | K001874 | 000 |
| H671PEEL10 | K001874 | 000 |
| H671PC02LPS0 | K001874 | 000 |
| H671PC02PS0 | K001874 | 000 |
| H671PC03PS0 | K001874 | 000 |
| H671PR31 | K001874 | 000 |
| H671PR21 | K001874 | 000 |
| H671PEEL30 | K001874 | 000 |
| H671PEEL20 | K001874 | 000 |
| H671PC3PS0 | K001874 | 000 |
| H671PC3PP0 | K001874 | 000 |
| H671PC3LPS0 | K001874 | 000 |
| H671PC2PS0 | K001874 | 000 |
| H671PC2PP0 | K001874 | 000 |
| H671PC2LPS0 | K001874 | 000 |
| H671PB1PP0 | K001874 | 000 |