POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM
FDA 510(k) clearance K070759 · decided 2007-05-21
Clearance details
- K-number
- K070759
- Device name
- POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM
- Applicant
- Vidacare Corporation
- Decision
- Substantially Equivalent
- Date received
- 2007-03-20
- Decision date
- 2007-05-21
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- FCF
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| POWERED EZ-IO BONE MARROW ASPIRATION SYSTEM (K062833) | Vidacare Corporation | 2006-11-30 |
| BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE (K984168) | United States Endoscopy Group, Inc. | 1999-12-07 |
| AMCATH DISPOSABLE BIOPSY FORCEPS (K915142) | Intl. Medical, Inc. | 1992-01-10 |
| OVAL CUP BIOPSY FORCEP (K911155) | Endovations | 1991-08-07 |
| PHARMA-PLAST RECTAL TIP (K843477) | Zimmar Consulting , Ltd. | 1984-12-05 |
Recalls involving this device
No recalls on record reference this clearance.