510(k) K070759
- Device
- POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM
- Applicant
- VIDACARE CORPORATION
- 510(k) number
- K070759
- Product code
- FCF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-05-21
- Date received
- 2007-03-20
- Regulation
- 876.1075
- Classification name
- Instrument, Biopsy, Mechanical, Gastrointestinal
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- GRACE HOLLAND
- Address
- 3722 Ave. Sausalito Irvine CA US 92606 92606
FDA Registration Numbers#
- 3011137372
Source Documents#
Other 510(k) Records For Product Code FCF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K062833 | POWERED EZ-IO BONE MARROW ASPIRATION SYSTEM | Vidacare Corporation | 2006-11-30 |
| K984168 | BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE | United States Endoscopy Group, Inc. | 1999-12-07 |
| K915142 | AMCATH DISPOSABLE BIOPSY FORCEPS | Intl. Medical, Inc. | 1992-01-10 |
| K911155 | OVAL CUP BIOPSY FORCEP | Endovations | 1991-08-07 |
| K843477 | PHARMA-PLAST RECTAL TIP | Zimmar Consulting , Ltd. | 1984-12-05 |
Legacy Summary#
summary
FDA Review#
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