510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955461Substantially Equivalent

Transtracheal Catheter (Acc. Ravussin).

VBM Medizintechnik GmbH, Roy UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955461 is the FDA 510(k) clearance record for TRANSTRACHEAL CATHETER (ACC. RAVUSSIN)., a class II device, cleared for VBM Medizintechnik GmbH on under FDA product code BTO (Tube, Tracheostomy (W/Wo Connector)). FDA records list 3 510(k) clearances for VBM Medizintechnik GmbH, from to . As of , FDA records show 3 recalls naming K955461.

Clearance record

Decision date
Received
(476 days to decision)
Product code
BTO Tube, Tracheostomy (W/Wo Connector)
Regulation
21 CFR 868.5800
Device class
Class II
Review panel
Anesthesiology
Applicant
VBM Medizintechnik GmbH 6072 S. 2550 W., Roy UT
510(k) summary
Statement
Third party review
No

Clearances, product code BTO

Trailing 12 months
1 clearance under product code BTO in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BTO, 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 20261
October 20260