The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Liver Tamponade Balloon.
| Device ID | K010450 |
| 510k Number | K010450 |
| Device Name: | LIVER TAMPONADE BALLOON |
| Classification | Balloon, Liver Tamponade |
| Applicant | COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington, IN 47402 |
| Contact | Lisa Hopkins |
| Correspondent | Lisa Hopkins COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington, IN 47402 |
| Product Code | NGU |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-15 |
| Decision Date | 2001-09-06 |