The following data is part of a premarket notification filed by Cordis Corp., A Johnson & Johnson Co. with the FDA for Optease Vena Cava Filter And Retrieval Catheter.
| Device ID | K091077 |
| 510k Number | K091077 |
| Device Name: | OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER |
| Classification | Filter, Intravascular, Cardiovascular |
| Applicant | CORDIS CORP., A JOHNSON & JOHNSON CO. 430 RTE 22 EAST Bridgewater, NJ 08807 |
| Contact | Karen Wilk |
| Correspondent | Karen Wilk CORDIS CORP., A JOHNSON & JOHNSON CO. 430 RTE 22 EAST Bridgewater, NJ 08807 |
| Product Code | DTK |
| CFR Regulation Number | 870.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-14 |
| Decision Date | 2010-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705032009420 | K091077 | 000 |
| 20705032009413 | K091077 | 000 |