Occlusion Detection Dressing Kit
FDA 510(k) clearance K171499 · decided 2017-09-22
Clearance details
- K-number
- K171499
- Device name
- Occlusion Detection Dressing Kit
- Applicant
- Cardinalhealth
- Decision
- Substantially Equivalent
- Date received
- 2017-05-23
- Decision date
- 2017-09-22
- Days to decision
- 122 days
- Clearance type
- Traditional
- Product code
- OMP
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Waukegan, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Cardinal Health Multifunctional Defibrillation Electrode (P190007) | Cardinalhealth | 2020-08-07 |