SALINE IV FLUSH SYRINGE
FDA 510(k) clearance K002142 · decided 2002-01-28
Clearance details
- K-number
- K002142
- Device name
- SALINE IV FLUSH SYRINGE
- Applicant
- Emt-Rx
- Decision
- Substantially Equivalent
- Date received
- 2000-07-17
- Decision date
- 2002-01-28
- Days to decision
- 560 days
- Clearance type
- Traditional
- Product code
- FOZ
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Raleigh, NC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Emt-Rx
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 |
|---|---|---|
| Normal Saline 3ml in 12ml Syringe. The product is shipped 120 units per carton recall (Z-1235-2007) | B. Braun Medical, Inc. | 2007-09-20 |
| Normal Saline 10ml in 12ml Syringe. The product is shipped in 120 units per carton. recall (Z-1236-2007) | B. Braun Medical, Inc. | 2007-09-20 |