The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Sorenson Thermo. Flow-direct Trans Pace Cath/lead.
| Device ID | K874465 |
| 510k Number | K874465 |
| Device Name: | SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD |
| Classification | Catheter, Flow Directed |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Contact | Frederick Gustafson |
| Correspondent | Frederick Gustafson ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | DYG |
| CFR Regulation Number | 870.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-30 |
| Decision Date | 1988-05-25 |