The following data is part of a premarket notification filed by Davol, Inc. with the FDA for 8 Fr Single Lumen High Performance Catheter.
| Device ID | K910486 |
| 510k Number | K910486 |
| Device Name: | 8 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | DAVOL, INC. 3385 WEST 1820 Salt Lake City, UT 84104 |
| Contact | Jack Speer |
| Correspondent | Jack Speer DAVOL, INC. 3385 WEST 1820 Salt Lake City, UT 84104 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-06 |
| Decision Date | 1991-04-19 |