BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET
FDA 510(k) clearance K011984 · decided 2001-08-29
Clearance details
- K-number
- K011984
- Device name
- BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET
- Applicant
- Becton, Dickinson & CO
- Decision
- Substantially Equivalent
- Date received
- 2001-06-26
- Decision date
- 2001-08-29
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- FMI
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Franklin Lakes, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Becton
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD Vacutainer Push Button collection Set; Non-Pyrogenic, Sterile, Rx only; 23 G x 3/4 x 12 recall (Z-0816-2011) | Becton Dickinson & Company | 2010-12-27 |
| BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder;Catalog Number : recall (Z-0589-2008) | Becton Dickinson & Company | 2008-01-23 |
| BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder; Catalog Number: recall (Z-0590-2008) | Becton Dickinson & Company | 2008-01-23 |
| BD Vacutainer Push Button Blood Collection Set with Pre-attached Holder. Non-pyrogenic 100 recall (Z-0034-2007) | Becton Dickinson & Company | 2006-10-12 |
| BD Vacutainer Push Button Blood Collection Set with Pre-Attached holder. recall (Z-0372-06) | Becton Dickinson & Company | 2006-01-11 |
| VACUTAINER Brand Push Button Blood Collection Sets. recall (Z-0549-04) | Becton Dickinson & Company | 2004-02-25 |