The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Modification To Model 5866-37m Lead Adaptor Kit.
Device ID | K000210 |
510k Number | K000210 |
Device Name: | MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT |
Classification | Pacemaker Lead Adaptor |
Applicant | MEDTRONIC VASCULAR 4000 LEXINGTON AVE. N Shoreview, MN 55126 -2983 |
Contact | Michael Johnson |
Correspondent | Michael Johnson MEDTRONIC VASCULAR 4000 LEXINGTON AVE. N Shoreview, MN 55126 -2983 |
Product Code | DTD |
CFR Regulation Number | 870.3620 [🔎] |
Decision | Se Subject To Tracking Reg (ST) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-01-24 |
Decision Date | 2000-02-23 |