The following data is part of a premarket notification filed by Maquet Cardiovascular, Llc with the FDA for Harvesting Cannula.
Device ID | K132743 |
510k Number | K132743 |
Device Name: | HARVESTING CANNULA |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | MAQUET CARDIOVASCULAR, LLC 45 BARBOUR POND DRIVE Wayne, NJ 07470 |
Contact | Mark Dinger |
Correspondent | Mark Dinger MAQUET CARDIOVASCULAR, LLC 45 BARBOUR POND DRIVE Wayne, NJ 07470 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-09-03 |
Decision Date | 2013-12-03 |
Summary: | summary |