FDA product code NZW: Heparin, Vascular Access Flush
NZW is the FDA product code for heparin, vascular access flush. It is a Class II device, regulated under 21 CFR 880.5200 and reviewed by the General Hospital panel. FDA has cleared 7 510(k) submissions under NZW, from 6 different applicants. The average 510(k) review took 203 days (median 187). FDA has posted 44 recalls for NZW devices, 1 initiated in the last five years.
Definition
Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.
Classification
| Field | Value |
|---|---|
| Device name | Heparin, Vascular Access Flush |
| Device class | Class II |
| Regulation | 21 CFR 880.5200 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for NZW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 69 |
Compare with all 510(k) review times · Search every NZW clearance
Top NZW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Excelsior Medical Corp. | 2 | 2007-02-23 |
| Becton, Dickinson and Company | 1 | 2017-02-27 |
| Excelsior Medical Corporation | 1 | 2014-11-14 |
| App Pharmaceuticals, LLC | 1 | 2010-06-18 |
| Medefil, Inc. | 1 | 2010-02-03 |
1 more applicants have NZW clearances. See the full list in Caduvo.
Most recent NZW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K163591 | Becton, Dickinson and Company | BD PosiFlush Heparin Lock Flush Syringe | 2017-02-27 | 69 |
| K133446 | Excelsior Medical Corporation | HEPARIN LOCK / FLUSH SYRINGES | 2014-11-14 | 367 |
| K092938 | App Pharmaceuticals, LLC | HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710 | 2010-06-18 | 267 |
| K092491 | Medefil, Inc. | MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES | 2010-02-03 | 174 |
| K090680 | Becton, Dickinson & CO | HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE | 2009-06-10 | 86 |
Recalls for NZW devices
44 product recalls in 11 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-05-25.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code NZW?
NZW is the FDA product code for heparin, vascular access flush. It is a Class II device, regulated under 21 CFR 880.5200 and reviewed by the General Hospital panel.
What device class is NZW?
Class II, regulation 21 CFR 880.5200. Typical premarket route: 510(k).
How long does a 510(k) take for product code NZW?
Across 7 cleared submissions the average was 203 days from receipt to decision (median 187).
Which companies have the most NZW clearances?
Excelsior Medical Corp. (2); Becton, Dickinson and Company (1); Excelsior Medical Corporation (1); App Pharmaceuticals, LLC (1); Medefil, Inc. (1).
Have NZW devices been recalled?
Yes: 44 product recalls across 11 recall events; the most recent began 2022-05-25.
Next steps
- Run an FDA pathway report with predicate devices for product code NZW
- Run a recall and safety report across every NZW manufacturer
- Watch product code NZW 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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