The following data is part of a premarket notification filed by Kapp Surgical Instrument, Inc. with the FDA for Michler-kapp Cardiovascular Vent Catheter.
| Device ID | K200289 |
| 510k Number | K200289 |
| Device Name: | Michler-Kapp Cardiovascular Vent Catheter |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | Kapp Surgical Instrument, Inc. 4919 Warrensville Center Rd Cleveland, OH 44128 |
| Contact | Nicole Merrifield |
| Correspondent | William Mclain CRO Group, Inc 342 Main Street Leola, PA 17540 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-05 |
| Decision Date | 2021-01-28 |