FDA product code PVS: Fetal Blood Sampling Kit (Excludes Hiv Testing)
PVS is the FDA product code for fetal blood sampling kit (excludes hiv testing). It is a Class II device, regulated under 21 CFR 884.1560 and reviewed by the Obstetrics and Gynecology panel. Devices under PVS reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Fetal Blood Sampling Kit (Excludes Hiv Testing) |
| Device class | Class II |
| Regulation | 21 CFR 884.1560 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Recalls for PVS devices
openFDA lists no recalls for product code PVS.
Frequently asked questions
What is FDA product code PVS?
PVS is the FDA product code for fetal blood sampling kit (excludes hiv testing). It is a Class II device, regulated under 21 CFR 884.1560 and reviewed by the Obstetrics and Gynecology panel.
What device class is PVS?
Class II, regulation 21 CFR 884.1560. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PVS
- Run a recall and safety report across every PVS manufacturer
- Watch product code PVS 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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