510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K152310Substantially Equivalent

HeartLight Deflectable Sheath

CardioFocus, Inc., Marlborough MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K152310 is the FDA 510(k) clearance record for HeartLight Deflectable Sheath, a class II device, cleared for Cardiofocus, Inc. on under FDA product code DRA (Catheter, Steerable). FDA records list 5 510(k) clearances for Cardiofocus, Inc., from to . As of , FDA records show no recalls naming K152310.

Clearance record

Decision date
Received
(194 days to decision)
Product code
DRA Catheter, Steerable
Regulation
21 CFR 870.1280
Device class
Class II
Review panel
Cardiovascular
Applicant
Cardiofocus, Inc. 500 Nickerson, Rd. Suite 500-200, Marlborough MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRA

Trailing 12 months
1 clearance under product code DRA in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260