The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Balloon Thermodilution Catheter #7164&.
| Device ID | K823433 |
| 510k Number | K823433 |
| Device Name: | BALLOON THERMODILUTION CATHETER #7164& |
| Classification | Catheter, Flow Directed |
| Applicant | CRITIKON COMPANY,LLC 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Correspondent | 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 | 1982-11-16 |
| Decision Date | 1982-11-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60801902008758 | K823433 | 000 |
| 00801902004611 | K823433 | 000 |
| 00801902008749 | K823433 | 000 |
| 30801902003950 | K823433 | 000 |
| 30801902003967 | K823433 | 000 |
| 60801902004392 | K823433 | 000 |
| 40801902004558 | K823433 | 000 |
| 40801902004565 | K823433 | 000 |
| 40801902004619 | K823433 | 000 |
| 40801902008747 | K823433 | 000 |
| 00801902004567 | K823433 | 000 |