510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K875213Substantially Equivalent

Surecath - Itp II Percutaneous Port Access Device

Titan Medical, Inc., Arden Hills MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K875213 is the FDA 510(k) clearance record for SURECATH - ITP II PERCUTANEOUS PORT ACCESS DEVICE, a class II device, cleared for Titan Medical, Inc. on under FDA product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular). FDA records list 3 510(k) clearances for Titan Medical, Inc., from to . As of , FDA records show no recalls naming K875213.

Clearance record

Decision date
Received
(76 days to decision)
Product code
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Regulation
21 CFR 880.5965
Device class
Class II
Review panel
General Hospital
Applicant
Titan Medical, Inc. 1306 W. County Rd. F, #201, Arden Hills MN
Third party review
No

Clearances, product code LJT

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