The following data is part of a premarket notification filed by Bionomy, Inc. with the FDA for Occlusion Catheter.
| Device ID | K811276 |
| 510k Number | K811276 |
| Device Name: | OCCLUSION CATHETER |
| Classification | Catheter, Flow Directed |
| Applicant | BIONOMY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DYG |
| CFR Regulation Number | 870.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-08 |
| Decision Date | 1981-06-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840663101603 | K811276 | 000 |
| 00840663101597 | K811276 | 000 |
| 00840663101580 | K811276 | 000 |
| 00840663101573 | K811276 | 000 |
| 00840663101566 | K811276 | 000 |
| 00840663101559 | K811276 | 000 |