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 |