510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K921666Substantially Equivalent

Cardiac Theraphy System Scp 900

Ppg Hellige B.V., Lenexa KS / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921666 is the FDA 510(k) clearance record for CARDIAC THERAPHY SYSTEM SCP 900, a class II device, cleared for Ppg Hellige B.V. on under FDA product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)). FDA records list 3 510(k) clearances for Ppg Hellige B.V., from to . As of , FDA records show no recalls naming K921666.

Clearance record

Decision date
Received
(534 days to decision)
Product code
LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Regulation
21 CFR 870.5300
Device class
Class II
Review panel
Cardiovascular
Applicant
Ppg Hellige B.V. P.O. Box 15955, Lenexa KS
510(k) summary
Summary
Third party review
No

Clearances, product code LDD

Trailing 12 months

FDA records hold no clearances under product code LDD in the trailing twelve months.

FDA records show no clearances under product code LDD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LDD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260