510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042850Substantially Equivalent

Cardiodrive, Model 001-004115 (Non-Sterile); 001-1169-1 (Sterile)

Stereotaxis Inc, Saint Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042850 is the FDA 510(k) clearance record for CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE), a class II device, cleared for Stereotaxis, Inc. on under FDA product code DQY (Catheter, Percutaneous). FDA records list 28 510(k) clearances for Stereotaxis, Inc., from to . As of , FDA records show no recalls naming K042850.

Clearance record

Decision date
Received
(663 days to decision)
Product code
DQY Catheter, Percutaneous
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Stereotaxis, Inc. 4041 Forest Park Ave., Saint Louis MO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQY

Trailing 12 months
13 clearances under product code DQY in the twelve months to October 2026, July 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQY, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20260
March 20261
April 20262
May 20260
June 20262
July 20263
August 20262
September 20261
October 20260