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

Catheter, Ventricular

21 CFR 882.4100 / Neurology
FDA source (opens on fda.gov)

HCA is the FDA product code for Catheter, Ventricular, a class II device type, regulated under 21 CFR 882.4100. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
HCA
Device name
Catheter, Ventricular
Regulation
21 CFR 882.4100
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
10
Ingested recalls
6

Clearances, product code HCA

By decision year
10 clearances under product code HCA with a decision year between 1984 and 2017, 2002 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code HCA by decision year
YearClearances
19841
19981
19991
20011
20023
20031
20131
20171

Applicants with the most clearances

Product code HCA
Applicants holding the most 510(k) clearances under product code HCA
ApplicantClearances
Cerenovus, Inc.3
Aesculap Inc1
Bresagen, Inc.1
Image-Guided Neurologics, Inc.1
Innerspace, Inc.1
Medtronic PS Medical1
Mri Interventions, Inc.1
Parker Hannifin Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order