510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K993620Substantially Equivalent

Impresario

Del Mar Medical Systems, LLC, Irvine CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K993620 is the FDA 510(k) clearance record for IMPRESARIO, a class II device, cleared for Del Mar Medical Systems, LLC on under FDA product code DQK (Computer, Diagnostic, Programmable). FDA records list 2 510(k) clearances for Del Mar Medical Systems, LLC, from to . As of , FDA records show no recalls naming K993620.

Clearance record

Decision date
Received
(17 days to decision)
Product code
DQK Computer, Diagnostic, Programmable
Regulation
21 CFR 870.1425
Device class
Class II
Review panel
Cardiovascular
Applicant
Del Mar Medical Systems, LLC 1621 Alton Pkwy., Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code DQK

Trailing 12 months
26 clearances under product code DQK in the twelve months to October 2026, February 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code DQK, trailing twelve months
MonthClearances
November 20250
December 20254
January 20262
February 20265
March 20260
April 20263
May 20261
June 20263
July 20264
August 20262
September 20261
October 20261