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

Clamp, Carotid Artery

21 CFR 882.5175 / Neurology
FDA source (opens on fda.gov)

HCE is the FDA product code for Clamp, Carotid Artery, a class II device type, regulated under 21 CFR 882.5175. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HCE
Device name
Clamp, Carotid Artery
Regulation
21 CFR 882.5175
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code HCE

By decision year
2 clearances under product code HCE with a decision year between 1981 and 1987, 1981 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HCE by decision year
YearClearances
19811
19871

Applicants with the most clearances

Product code HCE
Applicants holding the most 510(k) clearances under product code HCE
ApplicantClearances
Cerenovus, Inc.1
New England Surgical Instrument Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code