FDA product code HCA: Catheter, Ventricular
HCA is the FDA product code for catheter, ventricular. It is a Class II device, regulated under 21 CFR 882.4100 and reviewed by the Neurology panel. FDA has cleared 10 510(k) submissions under HCA, from 8 different applicants. The average 510(k) review took 147 days (median 90). FDA has posted 6 recalls for HCA devices.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Ventricular |
| Device class | Class II |
| Regulation | 21 CFR 882.4100 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HCA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 277 |
Compare with all 510(k) review times · Search every HCA clearance
Top HCA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Codman & Shurtleff, Inc. | 3 | 2003-05-14 |
| Parker Hannifin Corp. | 1 | 2017-03-27 |
| Mri Interventions, Inc. | 1 | 2013-08-16 |
| Bresagen, Inc. | 1 | 2002-08-06 |
| Aesculap, Inc. | 1 | 2002-04-05 |
3 more applicants have HCA clearances. See the full list in Caduvo.
Most recent HCA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K161731 | Parker Hannifin Corp. | Cleveland Multiport Ventricular Catheter Set | 2017-03-27 | 277 |
| K123605 | Mri Interventions, Inc. | SMARTFLOW CATHETER | 2013-08-16 | 268 |
| K031123 | Codman & Shurtleff, Inc. | CODMAN BACTISEAL BARIUM STRIPED CATHETERS | 2003-05-14 | 35 |
| K021481 | Bresagen, Inc. | BRESAGEN CATHETER, MODEL CS-3000 | 2002-08-06 | 90 |
| K020728 | Aesculap, Inc. | MIETHKE SHUNT SYSTEM | 2002-04-05 | 30 |
Recalls for HCA devices
6 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-03-17.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code HCA?
HCA is the FDA product code for catheter, ventricular. It is a Class II device, regulated under 21 CFR 882.4100 and reviewed by the Neurology panel.
What device class is HCA?
Class II, regulation 21 CFR 882.4100. Typical premarket route: 510(k).
How long does a 510(k) take for product code HCA?
Across 10 cleared submissions the average was 147 days from receipt to decision (median 90).
Which companies have the most HCA clearances?
Codman & Shurtleff, Inc. (3); Parker Hannifin Corp. (1); Mri Interventions, Inc. (1); Bresagen, Inc. (1); Aesculap, Inc. (1).
Have HCA devices been recalled?
Yes: 6 product recalls across 4 recall events; the most recent began 2021-03-17.
Next steps
- Run an FDA pathway report with predicate devices for product code HCA
- Run a recall and safety report across every HCA manufacturer
- Watch product code HCA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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