The following data is part of a premarket notification filed by Cordis Neurovascular, Inc. with the FDA for Modification To: Agility Steerable Guidewires.
| Device ID | K010511 |
| 510k Number | K010511 |
| Device Name: | MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES |
| Classification | Wire, Guide, Catheter |
| Applicant | CORDIS NEUROVASCULAR, INC. 14000 N.W. 57TH CT. Miami Lakes, FL 33014 |
| Contact | Amarilys Machado |
| Correspondent | Amarilys Machado CORDIS NEUROVASCULAR, INC. 14000 N.W. 57TH CT. Miami Lakes, FL 33014 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-21 |
| Decision Date | 2001-03-01 |