The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Ldob Occlusion Balloon Catheter.
| Device ID | K002286 |
| 510k Number | K002286 |
| Device Name: | LDOB OCCLUSION BALLOON CATHETER |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington, IN 47402 |
| Contact | Mary A Gossard |
| Correspondent | Mary A Gossard COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington, IN 47402 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-27 |
| Decision Date | 2001-03-22 |