The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Obturator.
| Device ID | K914352 |
| 510k Number | K914352 |
| Device Name: | CORDIS OBTURATOR |
| Classification | Introducer, Catheter |
| Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Mirjam Barboza,m.d. |
| Correspondent | Mirjam Barboza,m.d. CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-30 |
| Decision Date | 1991-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705032009598 | K914352 | 000 |
| 10705032009591 | K914352 | 000 |
| 10705032009645 | K914352 | 000 |
| 10705032009638 | K914352 | 000 |
| 10705032009621 | K914352 | 000 |
| 10705032009614 | K914352 | 000 |