REPROCESSED HEART STABILIZERS AND POSITIONERS
FDA 510(k) clearance K063844 · decided 2007-03-15
Clearance details
- K-number
- K063844
- Device name
- REPROCESSED HEART STABILIZERS AND POSITIONERS
- Applicant
- Sterilmed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-12-26
- Decision date
- 2007-03-15
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- NQG
- Device class
- 1
- Regulation number
- 870.4500
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES (K070036) | Ascent Healthcare Solutions | 2007-08-17 |
| REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES (K070034) | Ascent Healthcare Solutions | 2007-08-17 |
Recalls involving this device
No recalls on record reference this clearance.