The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Cath Lab Monitoring Catheter.
| Device ID | K884065 |
| 510k Number | K884065 |
| Device Name: | CATH LAB MONITORING CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | C.R. BARD, INC. ONE PARK WEST Tewksbury, MA 01876 -1234 |
| Contact | Kevin E Daly |
| Correspondent | Kevin E Daly C.R. BARD, INC. ONE PARK WEST Tewksbury, MA 01876 -1234 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-26 |
| Decision Date | 1989-01-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994733652 | K884065 | 000 |