The following data is part of a premarket notification filed by Bard Access Systems, Inc. with the FDA for Site-rite Needle Guide Kits And Probe Cover Kit.
| Device ID | K042445 |
| 510k Number | K042445 |
| Device Name: | SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | BARD ACCESS SYSTEMS, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
| Contact | Charles Morreale |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-09-09 |
| Decision Date | 2004-10-19 |
| Summary: | summary |