510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021580Substantially Equivalent

Optilock Implantable Access Port, Models #1700-01, 1700-02, 1700-03, 1700-04 and 1700-05

LeMaitre Vascular Inc., Burlington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K021580 is the FDA 510(k) clearance record for OPTILOCK IMPLANTABLE ACCESS PORT, MODELS #1700-01, 1700-02, 1700-03, 1700-04 AND 1700-05, a class II device, cleared for LeMaitre Vascular, Inc. on under FDA product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular). FDA records list 35 510(k) clearances for LeMaitre Vascular, Inc., from to . As of , FDA records show no recalls naming K021580.

Clearance record

Decision date
Received
(274 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
LeMaitre Vascular, Inc. 26 Ray Ave., Burlington MA
510(k) summary
Statement
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