FDA product code JCY: Catheter, Infusion
JCY is the FDA product code for catheter, infusion. It is a Class I device, regulated under 21 CFR 878.4200 and reviewed by the General and Plastic Surgery panel. FDA has cleared 14 510(k) submissions under JCY, from 10 different applicants. The average 510(k) review took 79 days (median 78). FDA has posted 3 recalls for JCY devices.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Infusion |
| Device class | Class I |
| Regulation | 21 CFR 878.4200 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JCY clearance
Top JCY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| B. Braun Instruments | 4 | 1976-11-02 |
| Argon Medical Corp. | 2 | 1983-07-28 |
| Vas-Cath of Canada , Ltd. | 1 | 1986-10-24 |
| Superior Plastic Products Corp. | 1 | 1984-04-25 |
| Medical Components, Inc. | 1 | 1984-02-14 |
5 more applicants have JCY clearances. See the full list in Caduvo.
Most recent JCY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K863982 | Vas-Cath of Canada , Ltd. | VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY | 1986-10-24 | 10 |
| K840324 | Superior Plastic Products Corp. | SILICONE SUMP DRAIN 20 & 40 FRENCH | 1984-04-25 | 91 |
| K834615 | Medical Components, Inc. | TRIPLE LUMEN INFUSIONCATHETERS- | 1984-02-14 | 72 |
| K831453 | Argon Medical Corp. | SILCATH CENTRAL CATHETER TRAY W/18 GA | 1983-07-28 | 84 |
| K831451 | Argon Medical Corp. | SILCATH CENTRAL CATHETER TRAY SIZE- | 1983-06-08 | 34 |
Recalls for JCY devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-08-31.
| Year | Recalls |
|---|---|
| 2017 | 1 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement
- E0783 — Infusion pump system, implantable, programmable (includes all components, e.g., pump, catheter, connectors, etc.)
Frequently asked questions
What is FDA product code JCY?
JCY is the FDA product code for catheter, infusion. It is a Class I device, regulated under 21 CFR 878.4200 and reviewed by the General and Plastic Surgery panel.
What device class is JCY?
Class I, regulation 21 CFR 878.4200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JCY?
Across 14 cleared submissions the average was 79 days from receipt to decision (median 78).
Which companies have the most JCY clearances?
B. Braun Instruments (4); Argon Medical Corp. (2); Vas-Cath of Canada , Ltd. (1); Superior Plastic Products Corp. (1); Medical Components, Inc. (1).
Have JCY devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2017-08-31.
Next steps
- Run an FDA pathway report with predicate devices for product code JCY
- Run a recall and safety report across every JCY manufacturer
- Watch product code JCY 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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