HGW · Sampler, Blood, Fetal
Obstetrics/Gynecology · 21 CFR 884.1560 · Class 2
Overview
| Product Code | HGW |
|---|---|
| Device Name | Sampler, Blood, Fetal |
| Regulation | 21 CFR 884.1560 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
A fetal blood sampler is a device used to obtain fetal blood transcervically through an endoscope by puncturing the fetal skin with a short blade and drawing blood into a heparinized tube. The fetal blood pH is determined and used in the diagnosis of fetal distress and fetal hypoxia.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K891388 | 1570 - FETAL BLOOD SAMPLING KIT | Transidyne General Corp. | Mar 28, 1989 | SESE |
| K884685 | ROCKET FETAL BLOOD SAMPLING TRAY | A & A Medical, Inc. | Jan 12, 1989 | SESE |
| K831459 | FETAL BLOOD SAMPLING KIT #1560 | Transidyne General Corp. | Jun 30, 1983 | SESE |
| K810028 | FETAL BLOOD SAMPLING KIT MODEL 1560 | Transidyne General Corp. | Jan 16, 1981 | SESE |
Top Applicants
- Transidyne General Corp. — 3 clearances
- A & A Medical, Inc. — 1 clearance
