FDA product code HCD: Cannula, Ventricular
HCD is the FDA product code for cannula, ventricular. It is a Class I device, regulated under 21 CFR 882.4060 and reviewed by the Neurology panel. FDA has cleared 3 510(k) submissions under HCD, from 3 different applicants. The average 510(k) review took 110 days (median 114).
Classification
| Field | Value |
|---|---|
| Device name | Cannula, Ventricular |
| Device class | Class I |
| Regulation | 21 CFR 882.4060 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HCD clearance
Top HCD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alcyone Lifesciences, Inc. | 1 | 2015-04-16 |
| Surgivision, Inc. | 1 | 2011-01-26 |
| Camino Laboratories, Inc. | 1 | 1992-05-01 |
Most recent HCD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K150660 | Alcyone Lifesciences, Inc. | Alcyone MEMS Cannula (AMC) System | 2015-04-16 | 34 |
| K102101 | Surgivision, Inc. | SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA | 2011-01-26 | 183 |
| K920088 | Camino Laboratories, Inc. | CAMINO VENTRICULAR NEEDLE | 1992-05-01 | 114 |
Recalls for HCD devices
openFDA lists no recalls for product code HCD.
Frequently asked questions
What is FDA product code HCD?
HCD is the FDA product code for cannula, ventricular. It is a Class I device, regulated under 21 CFR 882.4060 and reviewed by the Neurology panel.
What device class is HCD?
Class I, regulation 21 CFR 882.4060. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HCD?
Across 3 cleared submissions the average was 110 days from receipt to decision (median 114).
Which companies have the most HCD clearances?
Alcyone Lifesciences, Inc. (1); Surgivision, Inc. (1); Camino Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HCD
- Run a recall and safety report across every HCD manufacturer
- Watch product code HCD 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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