The following data is part of a premarket notification filed by Hollister Incorporated with the FDA for Sleeved Ic.
| Device ID | K220667 |
| 510k Number | K220667 |
| Device Name: | Sleeved IC |
| Classification | Catheter, Straight |
| Applicant | Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 |
| Contact | Sandra Mullen |
| Correspondent | Sandra Mullen Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-07 |
| Decision Date | 2022-12-08 |