FDA product code PQK: Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
PQK is the FDA product code for percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access. It is a Class II device, regulated under 21 CFR 870.1252 and reviewed by the Cardiovascular panel. FDA has cleared 5 510(k) submissions under PQK, from 3 different applicants. The average 510(k) review took 84 days (median 98). 2 De Novo requests were granted under it. FDA has posted 1 recall for PQK devices.
Definition
Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access. This device is a single use percutaneous catheter system that creates an arteriovenous fistula in the arm of patients with chronic kidney disease who need hemodialysis.
Classification
| Field | Value |
|---|---|
| Device name | Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access |
| Device class | Class II |
| Regulation | 21 CFR 870.1252 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for PQK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 98 |
| 2019 | 4 | 80 |
Compare with all 510(k) review times · Search every PQK clearance
Top PQK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| C.R. Bard, Inc. | 2 | 2019-10-17 |
| Avenu Medical, Inc. | 2 | 2019-01-25 |
| Avenu Medical | 1 | 2019-08-09 |
Most recent PQK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K192239 | C.R. Bard, Inc. | WavelinQ Plus EndoAVF System | 2019-10-17 | 59 |
| K191114 | Avenu Medical | Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle | 2019-08-09 | 105 |
| K182796 | C.R. Bard, Inc. | WavelinQ 4F EndoAVF System | 2019-02-06 | 128 |
| K183615 | Avenu Medical, Inc. | Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle | 2019-01-25 | 30 |
| K181725 | Avenu Medical, Inc. | Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) | 2018-10-05 | 98 |
Recalls for PQK devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-04-12.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code PQK?
PQK is the FDA product code for percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access. It is a Class II device, regulated under 21 CFR 870.1252 and reviewed by the Cardiovascular panel.
What device class is PQK?
Class II, regulation 21 CFR 870.1252. Typical premarket route: 510(k).
How long does a 510(k) take for product code PQK?
Across 5 cleared submissions the average was 84 days from receipt to decision (median 98).
Which companies have the most PQK clearances?
C.R. Bard, Inc. (2); Avenu Medical, Inc. (2); Avenu Medical (1).
Have PQK devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2019-04-12.
Next steps
- Run an FDA pathway report with predicate devices for product code PQK
- Run a recall and safety report across every PQK manufacturer
- Watch product code PQK 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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