FDA product code PEH: Hemodialysis Catheter Luer End Cap
PEH is the FDA product code for hemodialysis catheter luer end cap. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under PEH. The average 510(k) review took 186 days (median 186). FDA has posted 1 recall for PEH devices.
Definition
For use in hemodialysis catheters to reduce hub infection.
Classification
| Field | Value |
|---|---|
| Device name | Hemodialysis Catheter Luer End Cap |
| Device class | Class II |
| Regulation | 21 CFR 876.5540 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for PEH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 129 |
Compare with all 510(k) review times · Search every PEH clearance
Top PEH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pursuit Vascular, Inc. | 2 | 2018-05-25 |
Most recent PEH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K180111 | Pursuit Vascular, Inc. | ClearGuard HD Antimicrobial Barrier Cap | 2018-05-25 | 129 |
| K131060 | Pursuit Vascular, Inc. | CLEARGUARD HD END CAP | 2013-12-16 | 244 |
Recalls for PEH devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-02-15.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code PEH?
PEH is the FDA product code for hemodialysis catheter luer end cap. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel.
What device class is PEH?
Class II, regulation 21 CFR 876.5540. Typical premarket route: 510(k).
How long does a 510(k) take for product code PEH?
Across 2 cleared submissions the average was 186 days from receipt to decision (median 186).
Which companies have the most PEH clearances?
Pursuit Vascular, Inc. (2).
Have PEH devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2018-02-15.
Next steps
- Run an FDA pathway report with predicate devices for product code PEH
- Run a recall and safety report across every PEH manufacturer
- Watch product code PEH 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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