FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPARROWHAWK DISPOSABLE
K Number: K010473
·
Decision Jun 6, 2001
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
22
Applicant Total
4
Review Days
106
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Basic Information
- Device Name
- SPARROWHAWK DISPOSABLE
- K Number
- K010473
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4075
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Atc Technologies, Inc.
- Date Received
- February 20, 2001
- Decision Date
- June 6, 2001
- Product Code
- DWZ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DWZ | Device, Biopsy, Endomyocardial | FDA class 2 | Cardiovascular |
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