510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K200083Substantially Equivalent

EMBA Hourglass Peripheral Embolization Device (PED)

Embolic Acceleration, LLC, Miami FL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200083 is the FDA 510(k) clearance record for EMBA Hourglass Peripheral Embolization Device (PED), a class II device, cleared for Embolic Acceleration, LLC on under FDA product code KRD (Device, Vascular, For Promoting Embolization). FDA records list one 510(k) clearance for Embolic Acceleration, LLC. As of , FDA records show no recalls naming K200083.

Clearance record

Decision date
Received
(30 days to decision)
Product code
KRD Device, Vascular, For Promoting Embolization
Regulation
21 CFR 870.3300
Device class
Class II
Review panel
Cardiovascular
Applicant
Embolic Acceleration, LLC 3451 Commerce Pkwy., Miami FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KRD

Trailing 12 months
7 clearances under product code KRD in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KRD, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20261
May 20260
June 20262
July 20262
August 20260
September 20260
October 20260