The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis 13f Catheter Sheath Introducer.
| Device ID | K000753 |
| 510k Number | K000753 |
| Device Name: | CORDIS 13F CATHETER SHEATH INTRODUCER |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Ariel Mactavish |
| Correspondent | Ariel Mactavish CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-08 |
| Decision Date | 2000-04-06 |