BECTON DICKINSON SYRINGE
FDA 510(k) clearance K992734 · decided 1999-10-01
Clearance details
- K-number
- K992734
- Device name
- BECTON DICKINSON SYRINGE
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1999-08-13
- Decision date
- 1999-10-01
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- MEG
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Franklin Lakes, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD SafetyGlide Allergy. REF 305950 Sterile Allergy Treatment Syringe Tray. The device is u recall (Z-1577-2013) | Becton Dickinson & Company | 2013-06-21 |
| BD 1mL SafetyGlide Allergy and Tuberculin Syringes. Reorder Number 305945 and 305950. recall (Z-1525-06) | Becton Dickinson & Company | 2006-09-28 |
| BD 1 mL BD Safety Glide tuberculin syringe with 27 G x 1/2 in. BD needle. recall (Z-0402-06) | Becton Dickinson & Company | 2006-01-18 |
| BD 1 mL BD Safety Glide Tuberculin syringe with 26 G x 3/8 in. BD needle. recall (Z-0403-06) | Becton Dickinson & Company | 2006-01-18 |
| BD 1 mL Allergist tray with 27 G x 1/2 in. BD Safety Glide. recall (Z-0404-06) | Becton Dickinson & Company | 2006-01-18 |
| BD 1 mL Allergist tray with 26G x 3/8 in. BD Safety Glide. recall (Z-0405-06) | Becton Dickinson & Company | 2006-01-18 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OXYCELL (N5798/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-07-24 |
| OXYCEL OXIDIZED (N5798/S005) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| OXYCELL (N5798/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| MINI BALLOON (P780011/S012) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-30 |
| MINI BALLOON (P780011/S011) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-18 |
| MINI BALLOON (P780011/S010) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-01-29 |
| MINI BALLOON (P780011/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-23 |
| BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-11-05 |