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 |