The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Infusion Port Balloon Thermodilution.
| Device ID | K833918 |
| 510k Number | K833918 |
| Device Name: | INFUSION PORT BALLOON THERMODILUTION |
| Classification | Catheter, Flow Directed |
| Applicant | CRITIKON COMPANY,LLC 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DYG |
| CFR Regulation Number | 870.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-14 |
| Decision Date | 1984-01-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40801902030649 | K833918 | 000 |
| 40801902008723 | K833918 | 000 |
| 40801902002981 | K833918 | 000 |
| 00801902030641 | K833918 | 000 |
| 00801902008725 | K833918 | 000 |
| 00801902002983 | K833918 | 000 |
| 30801902128875 | K833918 | 000 |
| 20801902181040 | K833918 | 000 |