The following data is part of a premarket notification filed by Cathlab Corp. with the FDA for Cathlab Silicone Occlusion Balloon Catheter.
| Device ID | K910916 |
| 510k Number | K910916 |
| Device Name: | CATHLAB SILICONE OCCLUSION BALLOON CATHETER |
| Classification | Occluder, Catheter Tip |
| Applicant | CATHLAB CORP. 17991 FITCH Irvine, CA 92714 |
| Contact | Daniel R Lucas |
| Correspondent | Daniel R Lucas CATHLAB CORP. 17991 FITCH Irvine, CA 92714 |
| Product Code | DQT |
| CFR Regulation Number | 870.1370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-05 |
| Decision Date | 1991-06-24 |