510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K860806Substantially Equivalent

Regulated Pressure Injector

Target Therapeutics, Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860806 is the FDA 510(k) clearance record for REGULATED PRESSURE INJECTOR, a class II device, cleared for Target Therapeutics on under FDA product code DXF (Catheter, Septostomy). FDA records list 70 510(k) clearances for Target Therapeutics, from to . As of , FDA records show no recalls naming K860806.

Clearance record

Decision date
Received
(27 days to decision)
Product code
DXF Catheter, Septostomy
Regulation
21 CFR 870.5175
Device class
Class II
Review panel
Cardiovascular
Applicant
Target Therapeutics 2100 S. Sepulveda Blvd., Los Angeles CA
Third party review
No

Clearances, product code DXF

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