BONE CEMENT RADIO-OPACIFIER
FDA 510(k) clearance K032388 · decided 2003-10-31
Clearance details
- K-number
- K032388
- Device name
- BONE CEMENT RADIO-OPACIFIER
- Applicant
- Cardinalhealth
- Decision
- Substantially Equivalent
- Date received
- 2003-08-04
- Decision date
- 2003-10-31
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- MYU
- Device class
- 2
- Regulation number
- 882.5300
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Waukegan, IL, 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 |
|---|---|---|
| TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA (K033230) | Parallax Medical, Inc. | 2003-12-12 |
| VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1 (K024359) | Vista Scientific, LLC | 2003-08-08 |
| TRACERS BONE CEMENT OPACIFIER (K023445) | Parallax Medical, Inc. | 2003-03-11 |
| BIOTRACE, MODEL 1730 (K002063) | Bryan Corp. | 2000-08-10 |
| PARALLAX TRACER RADIOPAQUE PARTICLES (K991893) | Parallax Medical, Inc. | 1999-08-13 |
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 |