Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010)
FDA 510(k) K251238 · Maquet Cardiovascular, LLC
Submission
- Device name
- Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010)
- Applicant
- Maquet Cardiovascular, LLC
Wayne, NJ, US - Received
- April 22, 2025
- Decision date
- May 30, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K191947 | VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension…GEI · Traditional | 09/17/2019SE |
| K153194 | VASOVIEW HemoPro Endoscopic Vessel Harvesting SystemGEI · Traditional | 04/19/2016SE |
| K153523 | FUSION Vascular GraftDSY · Traditional | 02/16/2016SE |
| K132743 | Harvesting CannulaGEI · Traditional | 12/03/2013SE |
| K131778 | Fusion Vascular Graft and Fusion Bioline Vascular GraftDSY · Traditional | 11/14/2013SE |
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Questions and answers
When was Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010) cleared by the FDA?
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010) (K251238) received a 510(k) decision of Substantially Equivalent on May 30, 2025, 38 days after the submission was received.
What is the product code of K251238?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.