Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K191947Substantially Equivalent

VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord

Maquet Cardiovascular LLC, Wayne NJ / Traditional, Substantially Equivalent

K191947 is the FDA 510(k) clearance record for VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord, a class II device, cleared for Maquet Cardiovascular, LLC on under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories). FDA's definition for product code GEI reads: "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...". FDA records list 14 510(k) clearances for Maquet Cardiovascular, LLC, from to . As of , FDA records show no recalls naming K191947.

Clearance record

Decision date
Received
(57 days to decision)
Product code
GEI Electrosurgical, Cutting & Coagulation & Accessories
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Maquet Cardiovascular, LLC 45 Barbour Pond Dr., Wayne NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GEI

Trailing 12 months
47 clearances under product code GEI in the twelve months to October 2026, June 2026 the highest month at 9.
Show the numbers
Monthly 510(k) clearances under FDA product code GEI, trailing twelve months
MonthClearances
November 20254
December 20251
January 20266
February 20263
March 20265
April 20265
May 20264
June 20269
July 20263
August 20262
September 20265
October 20260