Blade, Saw, Surgical, Cardiovascular
The Cardiovascular Surgical Saw Blade is a surgical accessory used in cardiovascular procedures, such as sternotomy, to cut through bone or other hard tissue, typically in conjunction with a powered or manual saw handle. It is classified as an FDA Class 1 device, representing the lowest level of regulatory concern, and is subject to general controls only. The product code is DWH and it is regulated under 21 CFR 878.4820 within the General, Plastic Surgery medical specialty.
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Basic Information
- Product Code
- DWH
- Device Class
- FDA class 1
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K904352 | CODMAN COLLINS RADIOPARENT STERNAL BLADES | Nov 21, 1990 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K862474 | HALL STERNUM SAW | Jul 17, 1986 | Substantially Equivalent | Hall Surgical, Division of Zimmer, Inc. |
| K850483 | MICRO-AIRE STERNUM SAW REPLACEMENT BLADES | Mar 01, 1985 | Substantially Equivalent | Micro-Aire Surgical Instruments, Inc. |
| K830189 | CARDIOVASCULAR SAW BLADES | Mar 24, 1983 | Substantially Equivalent | Temp Medical Products, Inc. |
FEI Numbers
This FDA classification entry is associated with 35 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 35 registration numbers. Click on an entry to view related FDA registrations.