The following data is part of a premarket notification filed by Catheter Innovations, Inc. with the FDA for Pasv Dual Lumen Peripherally Inserted Central Catheter (picc) Model Number Pic-numerous.
| Device ID | K981368 |
| 510k Number | K981368 |
| Device Name: | PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER PIC-NUMEROUS |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | CATHETER INNOVATIONS, INC. 3598 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Contact | Roger L Richins |
| Correspondent | Roger L Richins CATHETER INNOVATIONS, INC. 3598 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-15 |
| Decision Date | 1998-05-01 |