The following data is part of a premarket notification filed by Maquet Cardiovascular, Llc. with the FDA for Vasoview Hemopro Extension Cable, Vasoview Hemopro 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord.
| Device ID | K191947 |
| 510k Number | K191947 |
| Device Name: | VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord |
| 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 | 2019-07-22 |
| Decision Date | 2019-09-17 |
| Summary: | summary |