CAROTID ARTERY CLAMP & TOOLS
FDA 510(k) clearance K811821 · decided 1981-09-24
Clearance details
- K-number
- K811821
- Device name
- CAROTID ARTERY CLAMP & TOOLS
- Applicant
- New England Surgical Instrument Corp.
- Decision
- Substantially Equivalent
- Date received
- 1981-06-29
- Decision date
- 1981-09-24
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- HCE
- Device class
- 2
- Regulation number
- 882.5175
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- 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 |
|---|---|---|
| SELVERSTONE CLAMP SALIBI CLAMP (K870399) | Codman & Shurtleff, Inc. | 1987-03-06 |
Recalls involving this device
No recalls on record reference this clearance.