510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993376Substantially Equivalent

Enstylet Models Ec0010, Ec0020

Endocardial Solutions, Inc., St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993376 is the FDA 510(k) clearance record for ENSTYLET MODELS EC0010, EC0020, a class II device, cleared for Endocardial Solutions, Inc. on under FDA product code DRB (Stylet, Catheter). FDA records list 8 510(k) clearances for Endocardial Solutions, Inc., from to . As of , FDA records show no recalls naming K993376.

Clearance record

Decision date
Received
(90 days to decision)
Product code
DRB Stylet, Catheter
Regulation
21 CFR 870.1380
Device class
Class II
Review panel
Cardiovascular
Applicant
Endocardial Solutions, Inc. 1350 Energy Ln., Suite 110, St. Paul MN
510(k) summary
Summary
Third party review
No

Clearances, product code DRB

Trailing 12 months

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

FDA records show no clearances under product code DRB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRB, 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