The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Thermoset(tm) Closed Loop Delivery System.
| Device ID | K884318 |
| 510k Number | K884318 |
| Device Name: | THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM |
| Classification | Probe, Thermodilution |
| 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 | KRB |
| CFR Regulation Number | 870.1915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-13 |
| Decision Date | 1988-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840619047306 | K884318 | 000 |
| 00840619047290 | K884318 | 000 |
| 00840619047283 | K884318 | 000 |
| 00840619047276 | K884318 | 000 |
| 00840619047252 | K884318 | 000 |
| 10887709045764 | K884318 | 000 |
| 10840619044142 | K884318 | 000 |
| 10840619044128 | K884318 | 000 |