510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991864Substantially Equivalent

Rotaflow Centrifugal Pump System

Jostra Medizintechnik AG, Newark DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991864 is the FDA 510(k) clearance record for ROTAFLOW CENTRIFUGAL PUMP SYSTEM, a class II device, cleared for Jostra Medizintechnik AG on under FDA product code KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type). FDA records list 2 510(k) clearances for Jostra Medizintechnik AG, from to . As of , FDA records show 2 recalls naming K991864.

Clearance record

Decision date
Received
(457 days to decision)
Product code
KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Regulation
21 CFR 870.4360
Device class
Class II
Review panel
Cardiovascular
Applicant
Jostra Medizintechnik AG 2035 Sunset Lake Rd., Newark DE
510(k) summary
Summary
Third party review
No

Clearances, product code KFM

Trailing 12 months

FDA records hold no clearances under product code KFM in the trailing twelve months.

FDA records show no clearances under product code KFM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KFM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260