510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K052844Substantially Equivalent

Kavs - Catheter, Models 1107100 & 1107060

Richter & Rothe AG, Leipzig, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052844 is the FDA 510(k) clearance record for KAVS - CATHETER, MODELS 1107100 & 1107060, a class II device, cleared for Richter & Rothe AG on under FDA product code MJN (Catheter, Intravascular Occluding, Temporary). FDA records list one 510(k) clearance for Richter & Rothe AG. As of , FDA records show no recalls naming K052844.

Clearance record

Decision date
Received
(164 days to decision)
Product code
MJN Catheter, Intravascular Occluding, Temporary
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Richter & Rothe AG Wilhelm Leuschner Platz 12, Leipzig, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MJN

Trailing 12 months

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

FDA records show no clearances under product code MJN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MJN, 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