The following data is part of a premarket notification filed by Catheter Innovations, Inc. with the FDA for 6 Inch Mini-bone Extension Set With Luer Lock, Nes01s, 6 Inch Min-bone Extension Set With Luer Slip, Nes02s, 6 Inch Stat.
| Device ID | K980127 |
| 510k Number | K980127 |
| Device Name: | 6 INCH MINI-BONE EXTENSION SET WITH LUER LOCK, NES01S, 6 INCH MIN-BONE EXTENSION SET WITH LUER SLIP, NES02S, 6 INCH STAT |
| Classification | Set, Administration, Intravascular |
| 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 | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-14 |
| Decision Date | 1998-03-11 |