CARDIOVASCULAR SAW BLADES
FDA 510(k) clearance K830189 · decided 1983-03-24
Clearance details
- K-number
- K830189
- Device name
- CARDIOVASCULAR SAW BLADES
- Applicant
- Temp Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-01-19
- Decision date
- 1983-03-24
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- DWH
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, 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 |
|---|---|---|
| CODMAN COLLINS RADIOPARENT STERNAL BLADES (K904352) | Codman & Shurtleff, Inc. | 1990-11-21 |
| HALL STERNUM SAW (K862474) | Hall Surgical, Division of Zimmer, Inc. | 1986-07-17 |
| MICRO-AIRE STERNUM SAW REPLACEMENT BLADES (K850483) | Micro-Aire Surgical Instruments, Inc. | 1985-03-01 |
Recalls involving this device
No recalls on record reference this clearance.