The following data is part of a premarket notification filed by Cordis Corp. with the FDA for 6f & 7f Introducing Catheters (modification).
| Device ID | K001135 |
| 510k Number | K001135 |
| Device Name: | 6F & 7F INTRODUCING CATHETERS (MODIFICATION) |
| Classification | Introducer, Catheter |
| Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Dennis S Griffin |
| Correspondent | Dennis S Griffin CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-10 |
| Decision Date | 2000-07-03 |