CRITIFLO & CRITIFLO DOME
FDA 510(k) clearance K791844 · decided 1979-10-02
Clearance details
- K-number
- K791844
- Device name
- CRITIFLO & CRITIFLO DOME
- Applicant
- Gould, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-09-19
- Decision date
- 1979-10-02
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- KRA
- Device class
- 2
- Regulation number
- 870.1210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Gould
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 |
|---|---|---|
| DTX(tm) Plus DT-DL60 Continuous flush catheter recall (Z-0069-06) | Becton Dickinson Medical Systems | 2005-10-21 |
| CRITIFLOW(tm) TA4004 continuous flush catheter recall (Z-0070-06) | Becton Dickinson Medical Systems | 2005-10-21 |
| TAKHPQ60R continuous flow catheter. recall (Z-0071-06) | Becton Dickinson Medical Systems | 2005-10-21 |
| CRITIFLO(tm) TAK0460 continuous flow catheter recall (Z-0072-06) | Becton Dickinson Medical Systems | 2005-10-21 |
| DT-DL60-1 W/Bifurcated recall (Z-0073-06) | Becton Dickinson Medical Systems | 2005-10-21 |
| CRITIFLO(tm) flush kit. recall (Z-0074-06) | Becton Dickinson Medical Systems | 2005-10-21 |
| CRITIFLO(tm) FLUSH KIT recall (Z-0075-06) | Becton Dickinson Medical Systems | 2005-10-21 |