510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K945956Substantially Equivalent

Strato Medical Infuse-a-Cath Triple Lumen Silicone Catheter Systems

Strato Medical Corp., Beverly MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945956 is the FDA 510(k) clearance record for STRATO MEDICAL INFUSE-A-CATH TRIPLE LUMEN SILICONE CATHETER SYSTEMS, a class II device, cleared for Strato Medical Corp. on under FDA product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days). FDA records list 45 510(k) clearances for Strato Medical Corp., from to . As of , FDA records show no recalls naming K945956.

Clearance record

Decision date
Received
(182 days to decision)
Product code
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Regulation
21 CFR 880.5970
Device class
Class II
Review panel
General Hospital
Applicant
Strato Medical Corp. 123 Brimbal Ave., Beverly MA
510(k) summary
Summary
Third party review
No

Clearances, product code LJS

Trailing 12 months
3 clearances under product code LJS 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 LJS, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260