COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS
FDA 510(k) clearance K051264 · decided 2005-09-01
Clearance details
- K-number
- K051264
- Device name
- COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS
- Applicant
- Unomedical A/S
- Decision
- Substantially Equivalent
- Date received
- 2005-05-16
- Decision date
- 2005-09-01
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Roskilde, DK
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Unomedical 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 paradigm mio Infusion Sets MMT-921 The Paradigm mio infusion sets are in recall (Z-0202-2012) | Medtronic Minimed | 2011-11-17 |