REPROCESSED BALOON INFLATION DEVICE
FDA 510(k) clearance K053188 · decided 2006-05-04
Clearance details
- K-number
- K053188
- Device name
- REPROCESSED BALOON INFLATION DEVICE
- Applicant
- Sterilmed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-11-15
- Decision date
- 2006-05-04
- Days to decision
- 170 days
- Clearance type
- Traditional
- Product code
- NKU
- Device class
- 2
- Regulation number
- 870.1650
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sterilmed
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.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Balloon Inflation Device Model #'s: MED15-105 MED15-106 and SCI04527-01 The reprocessed Ba recall (Z-0546-2009) | Sterilmed Inc | 2009-01-13 |