510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K121168Substantially Equivalent

Aptus 18Fr Helifx Guide-22 Deflectable Length

Aptus Endosystems, Inc., Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121168 is the FDA 510(k) clearance record for APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH, a class II device, cleared for Aptus Endosystems, Inc. on under FDA product code OTD (Endovascular Suturing System). FDA's definition for product code OTD reads: "Provides fixation and sealing between and endovascular graft and the native artery". FDA records list 5 510(k) clearances for Aptus Endosystems, Inc., from to . As of , FDA records show no recalls naming K121168.

Clearance record

Decision date
Received
(113 days to decision)
Product code
OTD Endovascular Suturing System
Regulation
21 CFR 870.3460
Device class
Class II
Review panel
Cardiovascular
Applicant
Aptus Endosystems, Inc. 777 N. Pastoria Ave., Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OTD

Trailing 12 months

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

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