The following data is part of a premarket notification filed by Maquet Cardiovascular, Llc with the FDA for Vasoview Hemopro Endoscopic Vessel Harvesting System.
| Device ID | K153194 |
| 510k Number | K153194 |
| Device Name: | VASOVIEW HemoPro Endoscopic Vessel Harvesting System |
| 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 | 2015-11-04 |
| Decision Date | 2016-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00607567701250 | K153194 | 000 |