510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K002138Substantially Equivalent

Paradigm Silhouette, Models Mmt-377, 378, 379, 380

Maersk Medical A/S, Sylmar CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002138 is the FDA 510(k) clearance record for PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380, a class II device, cleared for Maersk Medical A/S on under FDA product code FPA (Set, Administration, Intravascular). FDA records list 13 510(k) clearances for Maersk Medical A/S, from to . As of , FDA records show 2 recalls naming K002138.

Clearance record

Decision date
Received
(43 days to decision)
Product code
FPA Set, Administration, Intravascular
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Maersk Medical A/S 12744 San Fernando Rd., Sylmar CA
510(k) summary
Summary
Third party review
No

Clearances, product code FPA

Trailing 12 months
5 clearances under product code FPA in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FPA, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260