The following data is part of a premarket notification filed by Maquet Cardiovascular, Llc with the FDA for Vasoview Hemopro 2 Endoscopic Vessel Harvesting System.
| Device ID | K101274 |
| 510k Number | K101274 |
| Device Name: | VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MAQUET CARDIOVASCULAR, LLC 170 BAYTECH DRIVE San Jose, CA 95134 |
| Contact | Mark H Smith |
| Correspondent | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-05-06 |
| Decision Date | 2010-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00607567700925 | K101274 | 000 |
| 00607567700918 | K101274 | 000 |
| 00607567700451 | K101274 | 000 |
| 00607567700406 | K101274 | 000 |