510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091808Unknown

Sensei Robotic Catheter System, Model 02057

Hansen Medical, Inc., Mountain View CA / Special, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091808 is the FDA 510(k) clearance record for SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057, a class II device, cleared for Hansen Medical, Inc. on under FDA product code DXX (System, Catheter Control, Steerable). FDA records list 17 510(k) clearances for Hansen Medical, Inc., from to . As of , FDA records show one recall naming K091808.

Clearance record

Decision date
Received
(84 days to decision)
Product code
DXX System, Catheter Control, Steerable
Regulation
21 CFR 870.1290
Device class
Class II
Review panel
Cardiovascular
Applicant
Hansen Medical, Inc. 800 E Middlefield Rd., Mountain View CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXX

Trailing 12 months
2 clearances under product code DXX in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXX, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260