The following data is part of a premarket notification filed by Medtronic Cardiac Surgical Products with the FDA for 24 Fr. Left Heart Vent Catheter With Pressure Monitoring Line, Model 12524.
| Device ID | K012143 |
| 510k Number | K012143 |
| Device Name: | 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524 |
| Classification | Catheter, Steerable |
| Applicant | MEDTRONIC CARDIAC SURGICAL PRODUCTS 620 WATSON SW Grand Rapids, MI 49504 -6393 |
| Contact | Melissa Harriger |
| Correspondent | Melissa Harriger MEDTRONIC CARDIAC SURGICAL PRODUCTS 620 WATSON SW Grand Rapids, MI 49504 -6393 |
| Product Code | DRA |
| CFR Regulation Number | 870.1280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-10 |
| Decision Date | 2001-10-24 |
| Summary: | summary |