The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Dual Lumen 5 Fr Perip Cent Ven Cath W/groshong Val.
| Device ID | K904558 |
| 510k Number | K904558 |
| Device Name: | DUAL LUMEN 5 FR PERIP CENT VEN CATH W/GROSHONG VAL |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less 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 | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-05 |
| Decision Date | 1991-02-11 |