PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380
FDA 510(k) clearance K002138 · decided 2000-08-29
Clearance details
- K-number
- K002138
- Device name
- PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380
- Applicant
- Maersk Medical A/S
- Decision
- Substantially Equivalent
- Date received
- 2000-07-17
- Decision date
- 2000-08-29
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Sylmar, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Maersk Medical A/S
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 |
|---|---|---|
| Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infu recall (Z-0524-2015) | Medtronic MiniMed Inc. | 2014-12-12 |