The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Occlusion Balloon Catheter, Model Venos.
| Device ID | K081052 |
| 510k Number | K081052 |
| Device Name: | OCCLUSION BALLOON CATHETER, MODEL VENOS |
| Classification | Catheter, Flow Directed |
| Applicant | Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor, FL 34683 |
| Contact | Mila Doskocil |
| Correspondent | Mila Doskocil Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor, FL 34683 |
| Product Code | DYG |
| CFR Regulation Number | 870.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-14 |
| Decision Date | 2008-06-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00836559007111 | K081052 | 000 |
| 00836559007104 | K081052 | 000 |
| 00836559007098 | K081052 | 000 |
| 00836559007081 | K081052 | 000 |
| 00836559007074 | K081052 | 000 |
| 00836559006930 | K081052 | 000 |
| 00836559006923 | K081052 | 000 |
| 00836559006916 | K081052 | 000 |
| 00836559006909 | K081052 | 000 |