510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K083321Substantially Equivalent

Cardio-View

Curlview Igt, LLC, Newton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083321 is the FDA 510(k) clearance record for CARDIO-VIEW, a class II device, cleared for Curlview Igt, LLC on under FDA product code DXJ (Display, Cathode-Ray Tube, Medical). FDA records list one 510(k) clearance for Curlview Igt, LLC. As of , FDA records show no recalls naming K083321.

Clearance record

Decision date
Received
(15 days to decision)
Product code
DXJ Display, Cathode-Ray Tube, Medical
Regulation
21 CFR 870.2450
Device class
Class II
Review panel
Cardiovascular
Applicant
Curlview Igt, LLC 1242 Chestnut St., Newton MA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code DXJ

Trailing 12 months
1 clearance under product code DXJ in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXJ, 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 20261
October 20260