VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608
FDA 510(k) clearance K982541 · decided 1998-10-28
Clearance details
- K-number
- K982541
- Device name
- VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608
- Applicant
- Becton Dickinson Vacutainer Systems
- Decision
- Substantially Equivalent
- Date received
- 1998-07-21
- Decision date
- 1998-10-28
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- FMI
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Franklin Lake, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Becton Dickinson Vacutainer Systems
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 Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608 recall (Z-0252-2020) | Becton Dickinson & Company | 2019-10-31 |